ACCU-CHEK NANO 05423066001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00365702637108), received between Nov 15, 2019 and Jan 5, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (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 18, 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.

• MalfunctionJan 5, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE NANO METER WAS READING IN THE INCORRECT UNIT OF MEASURE. THE CALLER REPORTED THAT THE BLOOD GLUCOSE DEVICE IS LABELED TO READ IN MG/DL, BUT CHANGED TO MMOL/L. THE CALLER REPORTED THE CUSTOMER RECEIVED A RESULT OF 11.5 MMOL/L.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11119015 ↗
• MalfunctionMar 30, 2020Smoking; Smoking

  THE CALLER REPORTED THAT THE NANO METER PRODUCED SMOKE WHEN CHANGING THE BATTERY OF THE DEVICE. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9897086 ↗
• MalfunctionNov 26, 2019Incorrect Measurement; Incorrect Measurement

  CUSTOMER STATES THAT HER NANO SYSTEM READS IN MMOL/L, RATHER THAN MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9375140 ↗
• InjuryNov 15, 2019Power Problem; Power Problem

  IT WAS REPORTED THAT THE METER WAS UNAVAILABLE FOR USE DUE TO AN ERROR MESSAGE THAT THE BATTERY HAS TO BE CHANGED. THE CUSTOMER EXPERIENCED A HIGH BLOOD GLUCOSE VALUE OF 600 MG/DL. THE PATIENT FELT LIGHT HEADED AND GENERAL MALAISE BETWEEN 11:00 AM AND 12:00 PM. SHE STATED THAT SHE WOULD HAVE NORMALLY TAKEN 1000 MG OF METFORMIN AT THIS TIME BUT SHE DID NOT TREAT HERSELF. HER SON DROVER HER TO THE HOSPITAL AND THEY ARRIVED AT 1:30, THEY PUT HER ON AN EKG AND SHE WAS DIAGNOSED WITH AN ANEURYSM AND ADMITTED. SHE WAS SCHEDULED FOR SURGERY AT 2:30 PM. DURING THE PREPARATION FOR SURGERY, SHE WAS GIVEN A BLOOD SUGAR TEST ON THE HOSPITAL METER AND GOT A RESULT OF 600 MG/DL. THEY DECIDED TO POSTPONE SURGERY UNTIL BLOOD SUGAR WAS NORMAL.

  Patient problems: Hyperglycemia

  MAUDE report 9327958 ↗