Accutrend Glucose Test Strips 11447475160Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00365702456105), received between Dec 2, 2021 and Feb 24, 2022 — classified as 2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE RESULTS FROM ACCUTREND PLUS METER SERIAL NUMBER (B)(4). AT 8:20AM THE RESULT WAS 108 MG/DL. AT 8:25 AM THE RESULT WAS 124 MG/DL. AT 8:34 AM THE RESULT WAS 141 MG/DL. THE SAME FINGERSTICK WAS USED TO OBTAIN ALL THREE TESTS. NONE OF THE RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13591356 ↗
• MalfunctionDec 2, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER QUESTIONED CHOLESTEROL AND GLUCOSE RESULTS ON AN ACCUTREND PLUS METER WITH SERIAL NUMBER (B)(4). THE REPORTER COULD NOT PROVIDE ANY SPECIFIC PATIENT COMPARISON RESULTS. A STAFF MEMBER TESTED ON THE METER AND THE GLUCOSE RESULT WAS 29 MG/DL "WHICH WAS OBVIOUSLY TOO LOW" AS THE STAFF MEMBER HAD NO HYPOGLYCEMIC SYMPTOMS AND FELT FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916812 ↗