FreeStyle 70792Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00699073707925), received between Aug 29, 2017 and Apr 23, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K092638); they may or may not involve this specific model.

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

• InjuryApr 23, 2021Unable to Obtain Readings; Device Displays Incorrect Message; Unable to Obtain Readings; Device Displays Incorrect Message

  A CUSTOMER REPORTED HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO AN UNSPECIFIED ERROR MESSAGE RECEIVED ON THE ADC BLOOD GLUCOSE METER. THE CUSTOMER EXPERIENCED SYMPTOMS OF DIZZINESS, DISORIENTATION, AND COULD NOT WALK, AND WAS INCAPABLE OF SELF-TREATING. THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL WHO DIAGNOSED HIM WITH HYPOGLYCEMIA AND GLUCOSE WAS ADMINISTERED INTRAVENOUSLY AS TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Confusion/ Disorientation; Dizziness; Hypoglycemia

  MAUDE report 11716446 ↗
• MalfunctionAug 29, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER WITHIN 10 MINUTES. RESULTS OF 140 MG/DL AND 19 MG/DL WERE PLOTTED ON THE PARKES ERROR GRID. THE RESULTS FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6827702 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092638. One submission often covers many models, so check the product and lot details in each record.

• Z-1211-2014 · Feb 19, 2014 · Terminated
  FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C). Use test strips only within the system opera
• Z-1212-2014 · Feb 19, 2014 · Terminated
  FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test St