One Drop 8000-10465Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00859509006019), received between Nov 17, 2017 and Nov 17, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “High Test Results” (1 report).

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 17, 2017High Test Results; High Test Results

  PATIENT CALLED IN BECAUSE THE ONE DROP CHROME METER IS SHOWING READINGS THAT ARE HIGHER THAN USUAL FOR HIM, EVEN WHEN HE HAS SYMPTOMS OF LOW BLOOD GLUCOSE. ADDITIONALLY, THE ONE DROP CHROME IS REPORTED TO MEASURE BLOOD-GLUCOSE 20-50 MG/DL HIGHER THAN HIS EMBRACE PRO. HE MEASURES HIS BLOOD-GLUCOSE 4-7 TIMES AND INJECTS ABOUT 40 UNITS OF INSULIN PER DAY. THE NIGHT PREVIOUS TO CALLING, HE FELT LIKE HIS BLOOD-GLUCOSE WAS GETTING LOW SO HE MEASURED WITH HIS ONE DROP CHROME (75 MG/DL) BUT REPORTED NEVER EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA AT 75 MG/DL. HIS SYMPTOMS WORSENED SO HE CHECKED WITH HIS EMBRACE PRO (35 MG/DL). THIS MEASUREMENT WAS REPORTED TO OCCUR 5-10 MINUTES AFTER THE FIRST. THERE IS NO INDICATION THAT MEDICAL PERSONNEL WERE REQUIRED TO STABILIZE HIS BLOOD-SUGAR. NO INFORMATION WAS PROVIDED ON WHETHER INSULIN WAS ADMINISTERED IN RESPONSE TO A ONE DROP CHROME MEASUREMENT PRIOR TO THE EVENT, AND IF SO, NEITHER THE MEASUREMENT VALUE NOR THE DOSAGE WAS PROVIDED.

  Patient problems: Hypoglycemia

  MAUDE report 7041269 ↗