Devices › System, test, blood glucose, over the counter
Device brand name · Bd test strips
Bd Paradigm Link Blood Glucose Monitor: medical device reports filed with FDA
1,180 reports name it, 2003–2007. Manufacturer given most often on reports: Becton Dickinson. Product code NBW.
- 1,180
- device reports naming the brand
- 0% of all MAUDE reports · about 52 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 1.1%
- classified as malfunction
- 90.4% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 1,180 reports that name the brand "Bd Paradigm Link Blood Glucose Monitor" (bd test strips), received between September 2003 and August 2007; the manufacturer given most often on reports is Becton Dickinson. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are other (76.4%), injury (22.5%) and malfunction (1.1%); across all system, test, blood glucose, over the counter reports (product code NBW) death is recorded in 0% and malfunction in 90.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are incorrect or inadequate test results (68.7%), high test results (19.1%) and low test results (4.3%). The patient problems coded most often are hospitalization required, blood glucose, low and therapy/non-surgical treatment, additional. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
No report naming Bd Paradigm Link Blood Glucose Monitor was received in the five years to August 2026; the latest was received in August 2007.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 431,760 reports carrying product code NBW. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Incorrect or inadequate test results | 811 | 68.7% | 9.2% |
| High test results | 225 | 19.1% | 6.2% |
| Low test results | 51 | 4.3% | 2.5% |
| Device displays incorrect message | 42 | 3.6% | 24% |
| High readingsreadings were too high | 23 | 1.9% | 1.1% |
| Incorrect, inadequate or imprecise result or readings | 15 | 1.3% | 5.6% |
| Use of incorrect control/treatment settings | 13 | 1.1% | 0.9% |
| Malfunction | 11 | 0.9% | 0.1% |
| False reading from device non-compliance | 10 | 0.8% | 1.1% |
| Replace | 9 | 0.8% | 3.8% |
| Erratic or intermittent display | 8 | 0.7% | 0.1% |
| Other (for use when an appropriate device code cannot be identified) | 8 | 0.7% | 0% |
| Output above specifications | 8 | 0.7% | 0.1% |
| Low readingsreadings were too low | 6 | 0.5% | 0.3% |
| Device expiration issue | 2 | 0.2% | 0.2% |
| Device issuea problem with the device | 2 | 0.2% | 0.1% |
| Device remains implanted | 1 | 0.1% | 0% |
| Improper or incorrect procedure or method | 1 | 0.1% | 0.4% |
| No display/image | 1 | 0.1% | 2% |
| Unable to obtain readings | 1 | 0.1% | 0.6% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Hospitalization required | 135 | 11.4% |
| Blood glucose, low | 110 | 9.3% |
| Therapy/non-surgical treatment, additional | 72 | 6.1% |
| Loss of consciousnesspassing out | 59 | 5% |
| Treatment with medication(s) | 55 | 4.7% |
| Blood glucose, high | 26 | 2.2% |
| Hypoglycemialow blood sugar | 20 | 1.7% |
| Other (for use when an appropriate patient code cannot be identified) | 19 | 1.6% |
| Seizures | 19 | 1.6% |
| Shaking/tremors | 8 | 0.7% |
| Reactiona reaction, type not specified | 7 | 0.6% |
| Overmedicated | 5 | 0.4% |
| Convulsion | 4 | 0.3% |
| Overdosea dose above the recommended amount | 4 | 0.3% |
| Complaint, ill-defined | 3 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Bd Paradigm Link Blood Glucose Monitor | Product code NBW | All MAUDE reports |
|---|---|---|---|
| Reports | 1,180 | 431,760 | 26,136,888 |
| Share of that pool | — | 0.3% | 0% |
| Classified as death, per 1,000 reports | 1 | 0 | 9 |
| Classified as injury | 22.5% | 8.8% | 36.2% |
| Classified as malfunction | 1.1% | 90.4% | 62.3% |
| Filed by the manufacturer | 99.9% | 99.3% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code NBW
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Ot Verio Iq Meter | 93,041 | 0 | 0% |
| Ot Verio2 Meter | 45,294 | 0 | 0% |
| Ot Ping Meter | 38,817 | 0 | 0% |
| Ot Ultralink Meter | 26,217 | 0 | 0% |
| Ot Verio Flex Meter | 13,503 | 0 | 0% |
| Precision Xtra | 11,696 | 6 | 0.1% |
| FreeStyle Lite | 12,244 | 430 | 0% |
| FreeStyle Freedom Lite | 11,028 | 694 | 0% |
| Neo Meter Optium FreeStyle | 10,691 | 132 | 0% |
| FreeStyle Precision Neo | 10,407 | 35 | 0% |
| Ot Verio Pro Meter | 6,716 | 0 | 0% |
| Ot Verio Test Strips | 6,351 | 0 | 0% |
| One Touch Ultralink Meter | 5,994 | 0 | 0% |
| Ot Ultra2 Meter | 5,142 | 0 | 0% |
| Ot Ping Enhanced Meter | 5,080 | 0 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Bd Paradigm Link Blood Glucose Monitor reports
How many FDA reports name Bd Paradigm Link Blood Glucose Monitor?
1,180 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
other (76.4%), injury (22.5%) and malfunction (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
incorrect or inadequate test results (68.7%), high test results (19.1%), low test results (4.3%), device displays incorrect message (3.6%) and high readings (1.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Bd Paradigm Link Blood Glucose Monitor was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.