ACCU-CHEK PERFORMA 05959551001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00365702457102), received between Oct 22, 2018 and Sep 8, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Image Display Error/Artifact” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2022Image Display Error/Artifact; Image Display Error/Artifact

  THE INITIAL REPORTER COMPLAINED OF A DISPLAY ISSUE WITH AN ACCU-CHEK PERFORMA PROFESSIONAL METER. THE CUSTOMER STATED THE ENTIRE LEFT SIDE OF THE DISPLAY SCREEN IS PIXELATED; THE CUSTOMER STATED A RESULT MAY NOT BE CLEARLY VISIBLE DUE TO THE ISSUE. THERE HAS BEEN NO MISINTERPRETATION OF RESULTS. THE CUSTOMER STATED THE METER CANNOT BE USED FOR TESTING IN THE CURRENT CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15381509 ↗
• MalfunctionNov 7, 2021Display Difficult to Read; Display Difficult to Read

  WE RECEIVED AN ALLEGATION OF A DISPLAY ISSUE WITH AN ACCU-CHEK PERFORMA METER. THE REPORTER ALLEGED THE DISPLAY WAS "NOT CLEAR." THE REPORTER REPLACED THE BATTERY AND THE METER POWERED ON AS EXPECTED. THE REPORTER ALLEGED THE BOTTOM HALF OF THE SEGMENTS MAKING UP THE TIME AND DATE WERE NOT LEGIBLE. THE POWER BUTTON WAS NOT RESPONDING WHEN ATTEMPTING TO COMPLETE A DISPLAY CHECK; THE SEGMENTS MAKING UP THE RESULTS FIELD COULD NOT BE CHECKED. THE REPORTER DID NOT KNOW IF THERE WERE MISSING SEGMENTS FROM THE RESULTS FIELD. NO PATIENT RESULTS WERE MISINTERPRETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12761653 ↗
• MalfunctionNov 6, 2018Display or Visual Feedback Problem

  THE CUSTOMER COMPLAINED OF MISSING SEGMENTS FROM THE DISPLAY OF THE COAGUCHEK XS METER WHICH COULD IMPACT THE INTERPRETATION OF THE RESULTS. THE CUSTOMER STATED THAT THERE WERE DIAGONAL LINES IN THE RESULTS FIELD OF THE DISPLAY. THE CUSTOMER PERFORMED A DISPLAY CHECK AND VERIFIED MISSING SEGMENTS IN THE RESULTS FIELD. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THERE WAS NO MISINTERPRETATION OF THE RESULTS. THE SUSPECT DEVICE WAS REQUESTED TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8041963 ↗
• MalfunctionOct 22, 2018Image Display Error/Artifact; Image Display Error/Artifact

  THE CUSTOMER COMPLAINED OF MISSING SEGMENTS FROM THE DISPLAY OF THE ACCU-CHEK PERFORMA METER WHICH COULD IMPACT THE INTERPRETATION OF THE RESULTS. THE CUSTOMER STATED THAT THERE WERE SEGMENTS MISSING FROM THE RESULTS AND TIME FIELDS OF THE DISPLAY. A DISPLAY CHECK WAS PERFORMED AND THE FIRST TWO DIGITS OF THE RESULTS FIELD WERE MISSING SEGMENTS. AFTER THE METER WAS POWERED ON THE RESULTS AND TIME FIELDS WERE MISSING SEGMENTS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THERE WAS NO MISINTERPRETATION OF RESULTS. THE METER WAS REQUESTED TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7991354 ↗