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StatSensor/StatStrip 1.75 (REF 53402)Recalls & reported problems

Nova Biomedical Corporation · StatStrip StatSensor Docking Station · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00385480534024), received between Dec 22, 2020 and Dec 22, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Melted” (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

Device problems

  • Melted1
  • Overheating of Device1
  • Smoking1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 22, 2020Melted; Overheating of Device; Smoking; Overheating of Device

    THE CUSTOMER REPORTED THAT THE STATSTRIP WIRELESS METER (1.75) S/N: (B)(4) HAD BEEN SITTING IN THE DOCKING STATION S/N: (B)(4) FOR APPROXIMATELY ONE WEEK. WHEN THE METER WAS REMOVED FROM THE DOCKING STATION, THERE WAS A SMALL PUFF OF BLACK SMOKE, THE PLASTIC CASE WAS SLIGHTLY MELTED AND THE CONNECTION PINS APPEARED RED. THE BATTERY WAS REMOVED AND THE DOCKING STATION UNPLUGGED. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION REPORTED. THIS IS REPORT 1 OF 2.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11059362 ↗

Other GLUCOSE OXIDASE, GLUCOSE devices

All GLUCOSE OXIDASE, GLUCOSE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.