Accu-Chek Coaguchek SoftclixRecalls & reported problems across all models

We found 3 models of Accu-Chek Coaguchek Softclix by Roche Diabetes Care GmbH in the FDA's device registry (GUDID). Together they are named in 58 adverse event reports in the FDA's MAUDE database, received between Sep 21, 2018 and Oct 31, 2025 — classified as 1 injury, 57 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (48 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Accu-Chek Coaguchek Softclix problems

Accu-Chek Coaguchek Softclix models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Accu-Chek Coaguchek Softclix 07313462001

  Multiple Use Blood Lancet For Single Patient Use Only
  46 reports
• Accu-Chek Coaguchek Softclix 08120242001

  Multiple Use Blood Lancet For Single Patient Use Only
  11 reports
• Accu-Chek Coaguchek Softclix 08015333001

  Multiple Use Blood Lancet For Single Patient Use Only
  1 report

Recent Accu-Chek Coaguchek Softclix adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Retraction Problem; Retraction Problem

  THERE WAS AN ALLEGATION OF A RETRACTION ISSUE WITH A COAGUCHEK SOFTCLIX LANCET DEVICE. THE PATIENT ALLEGED THAT A PROPERLY SEATED LANCET PROTRUDED FROM THE END CAP OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438572 ↗
• MalfunctionAug 15, 2025Ejection Problem; Ejection Problem

  THERE WAS AN ALLEGATION OF AN ISSUE WITH A COAGUCHEK SOFTCLIX LANCING DEVICE. IT WAS ALLEGED THAT THE DEVICE DID NOT LANCE THE CUSTOMER'S FINGER. DURING TROUBLESHOOTING, IT WAS DETERMINED THAT THE CUSTOMER HAD NOT PRESSED THE YELLOW RELEASE BUTTON ON THE DEVICE. IT WAS ALLEGED THAT THE LANCET FELL OUT OF THE SOFTCLIX DEVICE WHEN THE CAP WAS REMOVED. THE LANCET WAS PROPERLY SEATED BEFORE IT FELL OUT. IT WAS CONFIRMED THAT THE NEEDLE DID NOT PROTRUDE PAST THE CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22817115 ↗
• MalfunctionJul 29, 2025Retraction Problem; Retraction Problem

  THE INITIAL REPORTER COMPLAINED OF AN ISSUE WITH A COAGUCHEK SOFTCLIX LANCET DEVICE. A NEW LANCET WAS INSERTED INTO THE DEVICE, AND THE NEEDLE PROTRUDED FROM THE END CAP. THE LANCET WAS REINSERTED, AND THE NEEDLE NO LONGER PROTRUDED FROM THE END CAP. WHEN THE LANCET WAS PRIMED, THE LANCET PROTRUDED FROM THE END CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22642857 ↗
• MalfunctionMar 18, 2025Retraction Problem; Retraction Problem

  THE INITIAL REPORTER STATED THERE WAS AN ISSUE WITH A COAGUCHEK SOFTCLIX LANCET DEVICE. THE REPORTER STATED THAT A LANCET WAS PROPERLY SEATED IN THE DEVICE, BUT THE NEEDLE PROTRUDED PAST THE END CAP OF THE DEVICE. THE REPORTER NOTED THAT THE LANCET NEEDLE APPEARED LONGER THAN OTHER LANCETS IN THE BOX. THE REPORTER INSERTED A NEW LANCET AND THE NEEDLE DID NOT PROTRUDE PAST THE END CAP OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634929 ↗
• MalfunctionMar 14, 2025Material Fragmentation; Material Fragmentation

  WE RECEIVED AN ALLEGATION THAT A PROPERLY SEATED COAGUCHEK XS SOFTCLIX LANCET PROTRUDES FROM THE CORRECTLY POSITIONED END CAP WHEN THE CORRECT LANCET IS USED ON THE COAGUCHEK XS SOFTCLIX DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607766 ↗
• MalfunctionNov 5, 2024Retraction Problem; Retraction Problem

  WE RECEIVED AN ALLEGATION THAT A PROPERLY SEATED COAGUCHEK XS SOFTCLIX LANCET PROTRUDES FROM THE CORRECTLY POSITIONED END CAP WHEN THE CORRECT LANCET IS USED ON THE COAGUCHEK XS SOFTCLIX DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609879 ↗
• MalfunctionOct 9, 2024Retraction Problem; Retraction Problem

  IT WAS ALLEGED THAT A LANCET WAS PROTRUDING PAST THE END CAP OF A COAGUCHEK XS SOFTCLIX DEVICE. THE CUSTOMER WAS ACCIDENTALLY STUCK BY A LANCET PROTRUDING PAST THE END CAP OF THE COAGUCHEK XS SOFTCLIX DEVICE. THE CUSTOMER DID NOT REQUIRE TREATMENT. THE CUSTOMER BELIEVED THE LANCET WAS SEATED PROPERLY, BUT COULD NOT CONFIRM THIS AS THE LANCET HAD ALREADY BEEN REPLACED. THE CUSTOMER WAS ADVISED ON HOW TO PRIME AND FIRE THE DEVICE. THE LANCET NO LONGER PROTRUDED PAST THE END CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409495 ↗
• MalfunctionJul 18, 2024Retraction Problem; Retraction Problem

  ON (B)(6) 2024 WE RECEIVED AN ALLEGATION OF ONE CUSTOMER STATING THAT THE LANCET IS PROTRUDING PAST THE END OF THE CAP OF THEIR SOFTCLIX DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19773624 ↗
• MalfunctionMay 22, 2024Mechanical Jam; Mechanical Jam

  THERE WAS AN ALLEGATION OF A RETRACTION ISSUE WITH A COAGUCHEK XS SOFTCLIX LANCET DEVICE. THE CUSTOMER ALLEGED THAT CAP OF THE DEVICE NO LONGER TURNS AND THE NEEDLE PROTRUDES WHEN THE CAP IS IN PLACE. THE CUSTOMER STATED THAT WHEN THEY INSERT THE LANCET, NO YELLOW DOT IS IN THE CLEAR WINDOW. THE CUSTOMER ALLEGED THAT DID ACCIDENTALLY STICK HERSELF WITH THE PROTRUDING NEEDLE BUT DID NOT REQUIRE MEDICAL TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372316 ↗
• MalfunctionMar 25, 2024Retraction Problem; Retraction Problem

  THE CUSTOMER STATED THERE WAS AN ISSUE WITH THE COAGUCHEK SOFTCLIX LANCING DEVICE. THE CUSTOMER INDICATED THAT THE LANCET WAS PROTRUDING PAST THE END CAP OF THE LANCING DEVICE BEFORE PRIMING. THE CUSTOMER REMOVED THE CAP OF THE DEVICE AND CONFIRMED THAT THE LANCET WAS SEATED PROPERLY. THE CUSTOMER RE-INSTALLED THE CAP, BUT THE ISSUE PERSISTED. THE LANCET WAS STILL PROTRUDING PAST THE END CAP OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18969090 ↗
• MalfunctionMar 20, 2024Retraction Problem; Appropriate Device Problem Term/Code Not Available; Retraction Problem; Appropriate Device Problem Term/Code Not Available

  WE RECEIVED AN ALLEGATION THAT A PROPERLY SEATED COAGUCHEK XS SOFTCLIX LANCET PROTRUDES FROM THE CORRECTLY POSITIONED END CAP WHEN THE CORRECT LANCET IS USED ON THE COAGUCHEK XS SOFTCLIX DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942043 ↗
• MalfunctionMar 19, 2024Retraction Problem; Retraction Problem

  THERE WAS AN ALLEGATION OF A RETRACTION ISSUE WITH THE COAGUCHEK XS SOFTCLIX DEVICE. THE REPORTER WANTED TO CONFIRM IF THE LANCET WAS SEATED CORRECTLY EACH OF THE THREE TIMES IT POKED OUT OF THE END OF THE CAP WHEN PRIMING. THE REPORTER STATED THAT THE NEEDLE "POKED OUT" OF THE CAP WHEN THEY WERE PRIMING THE DEVICE WHICH OCCURRED THREE TIMES. ON TROUBLESHOOTING, THE REPORTER STATED THAT THE NEEDLE WAS NOT SHOWING WHEN THE CAP WAS PUT ON AND THE NEEDLE CAME OUT WHEN THE DEVICE WAS PRIMED. THE REPORTER STATED THAT THEY HAD TO REPRIME THE DEVICE A FEW TIMES BEFORE THE NEEDLE RETRACTED AND WAS READY FOR USE. THE REPORTER ALSO MENTIONED THAT RECENTLY, THE LANCET HAD NOT BEEN LANCING THE FINGER AS WELL. THE REPORTER STATED THERE WERE NO ACCIDENTAL FINGER STICKS AND THAT THEY WERE ABLE TO GET THE DEVICE TO WORK CORRECTLY AFTERWARD TO COMPLETE THE TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18928607 ↗
• MalfunctionMar 11, 2024Retraction Problem; Retraction Problem

  THE CUSTOMER REPORTED AN ISSUE WITH A COAGUCHEK XS SOFTCLIX LANCET DEVICE. THE CUSTOMER STATED THAT THE NEEDLE WAS PROTRUDING OUT OF THE SOFTCLIX LANCET DEVICE AFTER POKING THEIR FINGER. THE CUSTOMER NOTED THAT THE LANCET WAS PROTRUDING PAST THE CAP OF THE DEVICE PRIOR TO THE CUSTOMER POKING THEIR FINGER AS WELL. THE CUSTOMER CONFIRMED THAT THE LANCET WAS SEATED PROPERLY IN THE DEVICE. THE CUSTOMER CONFIRMED THEY WERE NOT HARMED DUE TO POKING THEIR FINGER WITH THE PROTRUDING LANCET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18875084 ↗
• MalfunctionMar 5, 2024Mechanical Problem; Mechanical Problem

  THE CUSTOMER ALLEGED THERE WAS AN ISSUE WITH A COAGUCHEK XS SOFTCLIX LANCET DEVICE. THE SOFTCLIX DEVICE HAD A NEEDLE PROTRUDING THROUGH THE DIAL CAP. THE CUSTOMER CONFIRMED THE LANCET WAS PLACED INTO THE DEVICE PROPERLY UNTIL IT CLICKED INTO PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837977 ↗
• MalfunctionFeb 27, 2024Retraction Problem; Retraction Problem

  THE CUSTOMER ALLEGED THERE WAS AN ISSUE WITH A COAGUCHEK XS SOFTCLIX LANCET DEVICE. THE CUSTOMER STATED THAT THE SOFTCLIX DEVICE WOULD NOT FIRE. THE CUSTOMER WAS ABLE TO INSERT A NEEDLE AND PUT THE CAP ON THE SOFTCLIX DEVICE. THE CUSTOMER WAS ALSO ABLE TO MOVE THE CAP TO DIFFERENT DEPTH SETTINGS. THE CUSTOMER WAS ABLE TO PRIME THE SOFTCLIX DEVICE AND IT SOUNDED LIKE IT FIRED. THE CUSTOMER THEN ALLEGED THAT THE NEEDLE COULD BE SEEN COMING OUT OF THE END OF THE DEVICE. THE CUSTOMER EJECTED THE NEEDLE FROM THE SOFTCLIX DEVICE. THE DEVICE WAS WORKING PROPERLY AFTER THIS. THE CUSTOMER PUT THE NEEDLE BACK INTO THE DEVICE AND IT APPEARED TO BE PROPERLY SEATED. THE CUSTOMER WAS ABLE TO PUT THE CAP ON THE DEVICE AND WAS ABLE TO ADJUST THE SETTINGS, BUT ALLEGED THAT THE LANCET NEEDLE WAS STILL EXTENDING PAST THE CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18790769 ↗

Other Roche Diabetes Care GmbH products

• Accu-Chek Combo3 models · 1,930 reports
• Accu-Chek Softclix4 models · 148 reports
• Accu-Chek Fastclix4 models · 122 reports
• Accu-Chek Spirit Cartridge2 models · 99 reports