ACCU-CHEK PERFORMA 07299702001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00365702602106), received between Sep 15, 2021 and Mar 7, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2023High Test Results; High Test Results

  THE INITIAL REPORTER ALLEGED THAT THE CLINICAL PICTURE WAS NOT MATCHING WITH THE GLUCOSE RESULTS FOR 1 PATIENT TESTED ON ACCU-CHEK PERFORMA METER SERIAL NUMBER: (B)(4) COMPARED TO ANOTHER METER. ON (B)(6) 2023 AT 3:13 P.M. THE ACCU-CHEK PERFORMA METER RESULT WAS 530 MG/DL. LATER IN THE DAY, THE PATIENT WAS TAKEN TO THE ER AND AT 4:31 P.M. THE ER'S METER RESULT WAS REPORTED AS 96 MG/DL. THE REPORTER STATED THAT BOTH LEVEL 1 AND LEVEL 2 CONTROLS WERE RAN ON THE MORNING OF ON (B)(6) 2023 AND THEY BOTH PASSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16495070 ↗
• MalfunctionJun 15, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT GLUCOSE RESULTS FOR ONE PATIENT TESTED WITH ACCU-CHEK PERFORMA METER SERIAL NUMBER (B)(4). AT 3:20 P.M., A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER, RESULTING IN A GLUCOSE VALUE OF 245 MG/DL. THE PATIENT WAS FEELING SHAKING, SO THE DOCTOR REQUESTED AN HBA1C TEST FOR THE PATIENT. WITHIN 8 MINUTES, THE HBA1C TEST CAME BACK NORMAL. AT 3:31 P.M., A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER, RESULTING IN A GLUCOSE VALUE OF 129 MG/DL. AT 3:33 P.M., A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER, RESULTING IN A GLUCOSE VALUE OF 90 MG/DL. THE REPORTER STATED THE PATIENT RECENTLY HAD A SPRAY TAN AND IT WAS ON HER HANDS DURING TIME OF SAMPLE COLLECTION. CONTROLS TESTED ON THE METER ON THE DAY OF THE EVENT WERE WITHIN RANGE. THE CUSTOMER CONTINUED TO RUN CONTROLS ON THE METER UNTIL (B)(6) 2022 AND ALL CONTROLS PASSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14693207 ↗
• MalfunctionSep 15, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS A COMPLAINT OF DISCREPANT GLUCOSE RESULTS FOR ONE PATIENT TESTED WITH ACCU-CHEK PERFORMA METER WITH AN UNKNOWN SERIAL NUMBER. THE RESULT FROM THE METER WAS 200 MG/DL. THE RESULT FROM THE METER WAS 110 MG/DL. THE TIMING BETWEEN TESTS WAS WITHIN TEN MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474422 ↗