RELION 09409971001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00681131403276), received between Feb 23, 2023 and Jan 23, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 49 MG/DL AND 147 MG/DL. THE PATIENT EXPERIENCED INTENSE SWEATING AND FELT LIKE SHE WAS GOING TO FAINT AT THE TIME OF THE 49 MG/DL RESULT BUT REMAINED CONSCIOUS. AT THAT TIME, THE PATIENT SELF-TREATED WITH ORANGE JUICE, FOOD, AND GLUCOSE TABLETS.

  Patient problems: Hypoglycemia

  MAUDE report 21217795 ↗
• MalfunctionJan 14, 2025Low Test Results; Low Test Results

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 25 MG/DL, 102 MG/DL, AND 108 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148885 ↗
• MalfunctionNov 11, 2024Imprecise or Erratic Results; Imprecise or Erratic Results

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 225 MG/DL AND 95 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20658514 ↗
• MalfunctionJun 3, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 522 MG/DL AND 243 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19455294 ↗
• MalfunctionOct 9, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: "HI" MG/DL (GREATER THAN 600 MG/DL) AND 180 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17896493 ↗
• MalfunctionFeb 23, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 419 MG/DL AND 101 MG/DL. THE PATIENT REPORTED THAT HE FINISHED UP EATING DINNER AND DID NOT WASH HIS HANDS PRIOR TO TESTING. THE PATIENT STATED THAT HE "MAY" HAVE HAD SOME ENCHILADA SAUCE ON HIS FINGER. HE WASHED HIS HANDS AND RETESTED WITH THE 101 MG/DL RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16432109 ↗