Accu-Chek Softclix 05509661001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00365702400108), received between Jan 24, 2019 and Jan 28, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252135 ↗
• MalfunctionFeb 1, 2023Retraction Problem; Retraction Problem

  THERE WAS AN ALLEGATION OF AN ISSUE WITH AN ACCU-CHEK SOFTCLIX LANCET DEVICE. THE REPORTER INITIALLY CALLED FOR ASSISTANCE IN TESTING. AS THE REPORTER WAS ATTEMPTING TO PUNCTURE THE FINGER WITH THE ACCU-CHEK SOFTCLIX DEVICE, THE REPORTER NOTICED THAT THE LANCET WAS EXPOSED AND PROTRUDING FROM THE END OF THE CAP. THE REPORTER STATED THAT THE LANCET AND CAP WERE PROPERLY SEATED IN THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16280072 ↗
• MalfunctionDec 13, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15971053 ↗
• MalfunctionJan 29, 2019Retraction Problem; Retraction Problem

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. THE PATIENT COMPLAINED THAT AFTER INSERTING A NEW LANCET AND PLACING THE CAP ON, THE NEEDLE PROTRUDED FROM THE END OF THE LANCING DEVICE PAST THE CAP. THE EVENTS INVOLVED A TOTAL OF 1 PATIENTS WITH THE FOLLOWING: COAGUCHEK SOFTCLIX. THE PATIENTS' AGES RANGED FROM (B)(6) TO (B)(6) FOR TWO PATIENTS. THE REMAINING PATIENTS' AGES WERE REQUESTED, BUT WERE NOT PROVIDED. THE PATIENT'S WEIGHT WAS REQUESTED, BUT NOT PROVIDED. THERE WAS ONE MALE. THE PATIENT'S RACE WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT'S ETHNICITY WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8286365 ↗
• MalfunctionJan 24, 2019Retraction Problem; Retraction Problem

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENTS. THE CUSTOMER HAD A BROKEN ACCU-CHEK SOFTCLIX LANCING DEVICE WHERE THE NEEDLE WAS PROTRUDING BEYOND THE CAP. THE EVENTS INVOLVED A TOTAL OF 1 PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8273359 ↗