FDA Adverse Event Injury Summary report: N

CVS GLUCOSE METER

MDR report key: 24604594 · Received March 16, 2026

Report

Report Number
MW5185238
Event Type
Injury
Date Received
March 16, 2026
Date of Event
March 6, 2026
Report Date
March 7, 2026
Manufacturer
AGAMATRIX, INC.
Product Code
NBW
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
UNKNOWN
Health Professional
*

Narratives

Description of Event or Problem · 0

CVS GLUCOSE METER - SEVERAL TIMES AND EVERY TIME EVER USED IT HAS A 20 POINT UP OR DOWN WINDOW- THIS COULD BE LIFE THREATENING FOR THOSE WHO SUFFER WITH DIABETES. MY SUGAR IS CALCULATED PRETTY NORMAL; IT OFTEN READS AROUND 20POINTS OFF AND THIS COULD TECHNICALLY BE LIFE THREATENING. THANK YOU. HAS READ ANYWHERE FROM 90-130. AT THIS POINT THE ENTIRE TEST MACHINE IS COMPLETELY OFF. THE DOCTORS OFFICE READS AT RIGHT AROUND 100. THANK YOU BUT 130 IS A LITTLE TOO OFF FOR MY LIKINGS AND IT'S CONSISTENTLY WRONG.

Description of Event or Problem · 0

ADDITIONAL INFORMATION RECEIVED ON 4/20/2026 FOR MW5185238 TO UPDATE THE MANUFACTURER NAME TO AGAMATRIX, INC.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
674520 CVS GLUCOSE METER SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW AGAMATRIX, INC. (01)100504428293307 8000-10830

Patients

Seq Age Sex Outcome Treatment
1 39 YR Female Life Threatening