Reported Reactions

Devices › System, test, blood glucose, over the counter

Device brand name · Bgm blood glucose monitor

Prestige Iq: medical device reports filed with FDA

335 reports name it, 2002–2011. Manufacturer given most often on reports: Home Diagnostics. Product code NBW.

335
device reports naming the brand
0% of all MAUDE reports · about 14 a year
0
reports, 12 months to August 2026
0 in the 12 months before
100%
classified as malfunction
90.4% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 335 reports that name the brand "Prestige Iq" (bgm blood glucose monitor), received between April 2002 and August 2011; the manufacturer given most often on reports is Home Diagnostics. 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 malfunction (100%); 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 replace (87.2%), failure to calibrate (49%) and calibration error (16.1%). The patient problems coded most often are no patient involvement, therapy/non-surgical treatment, aborted/stopped and blood glucose, high. 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 Prestige Iq was received in the five years to August 2026; the latest was received in August 2011.

By year received

0601202002: 1320022003: 12020032004: 5020042005: 3020052006: 4120062007: 3020072008: 2820082009: 1620092010: 420102011: 32011

Event type and report source

Event type, as classified on the report

Death0%0
Injury0%0
Malfunction100%335
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%335
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

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)ReportsShareShare across product code
Replace29287.2%3.8%
Failure to calibrate16449%0.1%
Calibration error5416.1%0%
Defective component339.9%0.1%
High test results247.2%6.2%
Device issuea problem with the device216.3%0.1%
Defective devicethe device was defective195.7%0.1%
Device displays incorrect message175.1%24%
Other (for use when an appropriate device code cannot be identified)164.8%0%
Incorrect or inadequate test results61.8%9.2%
No display/image51.5%2%
Low test results41.2%2.5%
Display or visual feedback problem30.9%0.5%
Output above specifications30.9%0.1%
Repair30.9%0.1%
Sensor problems30.9%0%
High readingsreadings were too high20.6%1.1%
Unable to obtain readings20.6%0.6%
Calibration problem10.3%0%
Component missing10.3%1.3%

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)ReportsShare
No patient involvement154.5%
Therapy/non-surgical treatment, aborted/stopped133.9%
Blood glucose, high10.3%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasurePrestige IqProduct code NBWAll MAUDE reports
Reports335431,76026,136,888
Share of that pool—0.1%0%
Classified as death, per 1,000 reports009
Classified as injury0%8.8%36.2%
Classified as malfunction100%90.4%62.3%
Filed by the manufacturer100%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

BrandReportsLatest 12 monthsClassified as death
Ot Verio Iq Meter93,04100%
Ot Verio2 Meter45,29400%
Ot Ping Meter38,81700%
Ot Ultralink Meter26,21700%
Ot Verio Flex Meter13,50300%
Precision Xtra11,69660.1%
FreeStyle Lite12,2444300%
FreeStyle Freedom Lite11,0286940%
Neo Meter Optium FreeStyle10,6911320%
FreeStyle Precision Neo10,407350%
Ot Verio Pro Meter6,71600%
Ot Verio Test Strips6,35100%
One Touch Ultralink Meter5,99400%
Ot Ultra2 Meter5,14200%
Ot Ping Enhanced Meter5,08000%

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 Prestige Iq reports

How many FDA reports name Prestige Iq?

335 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?

malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

replace (87.2%), failure to calibrate (49%), calibration error (16.1%), defective component (9.9%) and high test results (7.2%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Prestige Iq 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.