FDA Adverse Event
Summary report: N
ACCUCHECK ADVANTAGE
MDR report key: 421602
·
Received August 16, 2002
Report
- Report Number
- MW4003366
- Date Received
- August 16, 2002
- Date of Event
- July 12, 2002
- Report Date
- August 16, 2002
- Manufacturer
- ROCHE DIAGNOSTICS CORP
- Product Code
- CFR
- Report Source
- Voluntary report
- Reporter Location
- WI, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
PT WAS HAVING SOME UNUSUAL READINGS SO THEY CALLED THE 800 NUMBER (1-800-858-8072) AS DIRECTED ON MACHINE. WHEN THEY GAVE THE CO REP THE LOT# FROM THE STRIPS PT WAS USING, PT WAS TOLD THAT THE LOT# WAS MEANT FOR OVERSEAS DISTRIBUTION ONLY AND ARE NOT LEGAL TO SELL IN THE UNITED STATES. PT CONTACTED PHARMACIST WHO BECAME ANGRY AND LATER TOLD PT THAT THEIR LAWYER SAID IT IS LEGAL FOR THEM TO SELL THOSE STIRPS IN THE US.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCUCHECK ADVANTAGE | GLUCOSE TEST STRIP | CFR | ROCHE DIAGNOSTICS CORP | * | 445772 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |