Livongo Test StripsRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853553005004), received between Nov 13, 2020 and Nov 13, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (1 report).

1 other recall cover devices cleared under the same FDA submission (K133584); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2020Unable to Obtain Readings; Therapeutic or Diagnostic Output Failure

  LIVONGO GLUCOSE MONITOR ISSUES. BLOOD GLUCOSE STRIPS WILL NOT ABSORB BLOOD. THE METER CAN NOT READ THE STRIPS. I HAVE TRIED 8 STRIPS IN A SESSION AND CAN NOT GET RESULTS. I HAVE TRIED DIFFERENT LOTS OF THE STRIPS BUT THEY DO NOT ABSORB BLOOD. IT TAKES ME 5 TO TEN ATTEMPTS TO GET A READING. TRIED DIFFERENT ANGLES TO NO AVAIL. THE MANUFACTURER HAS SENT REPLACEMENT STRIPS BUT SAME OUTCOME. UNABLE TO DETERMINE IF IT'S THE STRIPS OR MONITOR. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 10843181 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133584. One submission often covers many models, so check the product and lot details in each record.

• Z-1587-2016 · Feb 18, 2016 · Terminated
  The Livongo Health In Touch Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for the self- monitoring of blood glucose by persons with diabetes