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 |