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StatStrip 1.0 (REF 44993)Recalls & reported problems

Nova Biomedical Corporation · StatStrip Glucose Meter With Battery and Quick Reference Guide · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00385480449939), received between Jul 13, 2020 and Jul 13, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device 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

Device problems

  • Use of Device Problem1

Patient problems

  • No Information1

Recent adverse event reports

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

  • InjuryJul 13, 2020Use of Device Problem; Use of Device Problem

    CUSTOMER CALLED TO INQUIRE ABOUT ANY DANGERS IMPOSED BY THE BEAM OF THE BARCODE SCANNER IN STATSTRIP GLUCOSE HOSPITAL METER PN 44993. A USER LOOKED INTO THE SCANNER OF A STATSTRIP METER. CUSTOMER REPORTED THEIR EYES HURT AND STARTED SEEING BLACK SHAPES. CUSTOMER WENT TO SEE THE HOSPITAL'S MEDICAL OFFICER TO REPORT THE EVENT AND SEEK CONSULTATION. MULTIPLE ATTEMPTS WERE MADE TO RECEIVE SPECIFIC RESULTS AND OR PATIENT SPECIFIC INFORMATION, HOWEVER; NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE FACILITY.

    Patient problems: No Information

    MAUDE report 10267424 ↗

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.