FreeStyle Precision H 80116Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00093815801160), received between Feb 27, 2018 and Oct 16, 2018 — classified as 2 injuries.

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

3 other recalls cover devices cleared under the same FDA submission (K070984); 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2018No Device Output; No Device Output

  A HEALTHCARE PROVIDER REPORTED THAT ON (B)(6) 2018 AT 5PM A CLINIC¿S ADC BLOOD GLUCOSE METER WOULD TURN ON WITH BUTTON PRESS, BUT NOT WITH TEST STRIP INSERTION, THEREBY PREVENTING A READING FROM BEING OBTAINED. IT WAS FURTHER REPORTED THE CUSTOMER/PATIENT BECAME ¿HYPERTENSIVE, DIAPHORETIC¿, AND SUBSEQUENTLY ¿LOST CONSCIOUSNESS¿. PARAMEDICS WERE CALLED AND UPON ARRIVAL RECEIVED A READING OF 20 MG/DL ON THEIR METER AND TRANSPORTED HIM TO A HOSPITAL. CALLER DID NOT KNOW THE SPECIFIC TREATMENT RENDERED BY THE PARAMEDICS OR AT THE HOSPITAL. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Diaphoresis; High Blood Pressure/ Hypertension; Loss of consciousness

  MAUDE report 7971963 ↗
• InjuryFeb 27, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  A PATROL OFFICER REPORTED THAT ON (B)(6) 2018 AT 11:00 A.M., A MAN WAS FOUND UNCONSCIOUS. THE PATROL OFFICER ATTEMPTED TO USE THE ADC METER TO TEST THE MAN'S GLUCOSE AND WAS UNSUCCESSFUL DUE TO AN ER-3 MESSAGE APPEARING ON THE METER DISPLAY. PARAMEDICS WERE CALLED AND UPON THEIR ARRIVAL AT 11:15 A.M., A BLOOD GLUCOSE RESULT OF 38 MG/DL WAS OBTAINED ON THE PARAMEDIC METER AND THE MAN WAS TREATED WITH D-50 GLUCOSE VIA INTRAVENOUS INFUSION. ONCE HE REGAINED CONSCIOUSNESS, HE WAS PROVIDED SOLID FOOD AND TRANSPORTED TO A HOSPITAL AT 11:40 A.M. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 7301716 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070984. One submission often covers many models, so check the product and lot details in each record.

• Z-1558-2020 · Nov 14, 2019 · Terminated
  FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
• Z-0998-2011 · Dec 22, 2010 · Terminated
  Abbott Diabetes Care, Precision Point of Care Blood Glucose Test Strips;
• Z-0994-2011 · Dec 22, 2010 · Terminated
  Abbott Diabetes Care Precision Xceed Pro Blood Glucose Test Strips