Accu-Chek Softclix 11893238160Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00075537009710), received between Feb 19, 2020 and Jun 3, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE STERILITY CAP OF ONE LANCET WAS MISSING. THE MISSING ITEM WAS APPARENT WHEN THE PATIENT RECEIVED THE LANCET BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22130788 ↗
• MalfunctionFeb 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT 2 TO 3 LANCETS WERE UNCAPPED OUT-OF-BOX. THE PATIENT RECEIVED AN ACCIDENTAL FINGERSTICK. THE PATIENT DID NOT SEEK MEDICAL ATTENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21450310 ↗
• MalfunctionNov 27, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT SPLINTERS/SMALL FRAGMENTS BROKE OFF FROM THE LANCET AND GOT STUCK IN THE PATIENT'S FINGER. THE PATIENT USED ANOTHER LANCET TO REMOVE THE FRAGMENTS FROM HER FINGER. SHE DID NOT NEED OR SEEK ANY MEDICAL ATTENTION. THE ISSUE OCCURRED 1 TO 2 TIMES WITH THIS UNKNOWN LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18213494 ↗
• MalfunctionNov 23, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT SPLINTERS/SMALL FRAGMENTS BROKE OFF THE LANCET AND GOT STUCK IN THE PATIENT'S FINGER. THE PATIENT USED ANOTHER LANCET TO REMOVE THE FRAGMENTS FROM HER FINGER. SHE DID NOT NEED OR SEEK ANY MEDICAL ATTENTION. THE PROBLEM STARTED WITH 4-5 LANCETS ABOUT 3 MONTHS AGO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18197409 ↗
• MalfunctionSep 1, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE LANCET TIP BROKE OFF AND WAS EMBEDDED IN THE PUNCTURE SITE ON FIVE OCCASIONS. THE CUSTOMER WAS ABLE TO REMOVE THE LANCET TIP FROM THREE PUNCTURE HOLES AND BELIEVES THAT THE LANCET BROKE OFF ON TWO MORE PUNCTURE SITES AS WELL. THE CUSTOMER DID NOT RECEIVE ANY MEDICAL ATTENTION OR TREATMENT.

  Patient problems: Impaired Healing

  MAUDE report 17668945 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION ON HER FINGER IN WHICH SHE ALLEGED IT WAS CAUSED BY PUNCTURING HER FINGER WITH THE LANCET DEVICE. THE PATIENT EXPERIENCED PAIN AND RED STREAKS ON HER INFECTED FINGER. THE TIP OF HER FINGER BECAME NUMB. THE PATIENT MADE MULTIPLE TRIPS TO THE DOCTOR BECAUSE THE FINGER WAS NOT HEALING. THE PATIENT RECEIVED TWO ANTIBIOTICS AND ANTIFUNGAL CREAM THAT DIDN'T RESOLVE THE ISSUE. THE PATIENT WAS EVENTUALLY PRESCRIBED BACTRIM, WHICH CLEARED UP THE INFECTION. THE INFECTION PERSISTED FOR APPROXIMATELY TWO MONTHS BEFORE HEALING.

  Patient problems: Skin Infection

  MAUDE report 14240970 ↗
• MalfunctionOct 27, 2020Delivered as Unsterile Product; Component Missing; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT STERILITY CAPS WERE MISSING IN THE PACKAGING OF LANCET DEVICES. THE CUSTOMER'S WIFE STATED THAT SHE ACCIDENTALLY PRICKED HER FINGER AFTER PUTTING HER HAND INTO THE LANCET PACKAGE. THE WIFE DID NOT NEED TO SEEK MEDICAL ATTENTION. NO ADVERSE EVENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10740741 ↗
• MalfunctionFeb 19, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A FRAGMENT OF THE LANCET BROKE OFF IN THE PATIENT'S FINGER. THE PATIENT WAS ABLE TO REMOVE THE LANCET HIMSELF. NO MEDICAL TREATMENT WAS REQUIRED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9727032 ↗