Single use only blood lancet with an integral sharps injury prevention feature: medical device reports filed with FDA

14,110 reports carry this product code, 1993–2026; 25 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

14,110
reports with this product code: 0.1% of all MAUDE reports; 80
reports, 12 months to August 2026: 95 in the 12 months before; 93.5%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code FMK is FDA's classification for "Single use only blood lancet with an integral sharps injury prevention feature" (general, Plastic Surgery panel), a class 2 device. 14,110 medical device reports carry this product code, 0.1% of the MAUDE database, from August 1993 to August 2026.

80 reports arrived in the 12 months to August 2026, down 16% from 95 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 (93.5%), injury (5.9%) and other (0.5%). 25 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Accu-Chek Multiclix	6,139	0	0%	99.5%
Softclix Lancet Device	2,959	80	0%	99.5%
Softclix Plus Lancet Device	1,135	0	0%	99.8%
Accu-Chek Fastclix	975	56	0%	99.2%
Softclix Plus Gt Lancet Device	282	0	0%	100%
Bd Microtainer Contact-Activated Lancet	212	10	0%	80.5%
Safe-T-Pro	152	0	0%	92.1%
Softclix Lancets	148	6	0%	52.2%
Ot Delica Lancing Device	14	0	0%	4.1%
EasyTouch	5	42	0%	96.8%
Accu-Chek Mobile Test Strips	3	0	0%	95.9%
Freestyle	3	26	0.1%	85.8%
One Touch Lancing Device	3	0	0%	1.8%
Accu-Chek	2	0	0%	41.5%
Accu-Chek Advantage	2	0	0.5%	56.1%
Freestyle Flash	2	0	0%	96.5%
Trueresult	2	0	0%	99.7%
Accu-Chek Aviva Test Strips	1	0	0%	96.3%
Accu-Chek Comfort Curve Test Strips	1	0	0%	91.9%
Accu-Chek Rapid-D Infusion Set	1	0	0%	82.6%
Contour Test Strips 50	1	0	0%	94.6%
Easy Touch	1	0	0%	97.9%
Freestyle Freedom	1	6	0%	84.3%
Precision Xtra/Optium	1	0	0.1%	73.3%
Rsvr Mmt-326a 10pk Prdgm 1 8ml 13l	1	0	0.4%	95.5%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Roche Diagnostics	9,631	68.3%
Roche Diabetes Care	2,994	21.2%
Lifescan	191	1.4%
Becton Dickinson	141	1%
Abbott Diabetes Care	82	0.6%
Bayer Healthcare	80	0.6%
Mhc Medical Products	53	0.4%
Lifescan Europe	37	0.3%
Trividia Health	35	0.2%
Ascensia Diabetes Care US	32	0.2%
Bd Caribe	20	0.1%
Bayer	19	0.1%
Becton Dickinson And	15	0.1%
Abbott Diabetes Care USA	11	0.1%
Becton Dickinson & Franklin Lakes	9	0.1%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0%2

Injury5.9%831

Malfunction93.5%13,190

Other0.5%68

Not given0.1%19

Who filed

Manufacturer report98.2%13,855

Voluntary report1.1%150

User facility report0%0

Distributor report0.3%49

Not given0.4%56

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Retraction problem	12,131	86%
Replace	803	5.7%
Needle, unsheathed	220	1.6%
Spring loading mechanism problem	199	1.4%
Insufficient device problem information	177	1.3%
Delivered as unsterile product	153	1.1%
Breakthe device broke	146	1%
Material protrusion/extrusion	133	0.9%
Incorrect, inadequate or imprecise result or readings	120	0.9%
Material fragmentation	104	0.7%
Other (for use when an appropriate device code cannot be identified)	79	0.6%
Device damaged prior to usethe device was damaged before use	64	0.5%
Failure to fire	58	0.4%
Product quality problem	51	0.4%
Sticking	51	0.4%
Physical property issue	44	0.3%
Detachment of device or device componentpart of the device came off	43	0.3%
Difficult or delayed activation	42	0.3%
Detachment of device component	41	0.3%
Device contamination with chemical or other material	39	0.3%

Questions about single use only blood lancet with an integral sharps injury prevention feature reports

What is product code FMK?

FDA's classification code for "Single use only blood lancet with an integral sharps injury prevention feature", class 2, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.

How many reports carry this code?

14,110 reports through August 2026, 80 of them in the latest 12 months.

Which brands appear most often?

Accu-Chek Multiclix (6,139), Softclix Lancet Device (2,959), Softclix Plus Lancet Device (1,135), Accu-Chek Fastclix (975) and Softclix Plus Gt Lancet Device (282). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.