D-100 290-1004Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847817015953), received between May 19, 2017 and May 19, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Data Problem” (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.

• InjuryMay 19, 2017Patient Data Problem; Patient Data Problem

  THE PHYSICIAN TREATED THE PATIENT BASED ON THE INCORRECT RESULT, 11.2% HBA1C THAT APPEARS TO CAUSED PATIENT HARM. THE D-100 HEMOGLOBIN TESTING SYSTEM DATABASE REVIEW SHOWS THAT THE SYSTEM CORRECTLY TRANSMITTED A 5.5% HBA1C, NGSP VALUE TO LIS. THE CHANGE TO THE PATIENT'S HBA1C VALUE OCCURED OUTSIDE OF THE CUSTODY OF THE D-100 HEMOGLOBIN TESTING SYSTEM.

  Patient problems: Hyperglycemia

  MAUDE report 6579958 ↗