FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMPACT PLUS
MDR report key: 1061501
·
Received June 17, 2008
Report
- Report Number
- 1823260-2008-04776
- Event Type
- Malfunction
- Date Received
- June 17, 2008
- Date of Event
- June 15, 2008
- Report Date
- June 17, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K031755
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTS HER METER WAS SITTING ON THE TABLE UNDER A LAMP, AND IT EXPLODED WHILE USING THE COMPACT PLUS SYSTEM. CUSTOMER STATES SHE DID NOT BLOW INTO PIECES, SHE JUST HEARD A POP AND THE SCREEN WENT DARK. NO ADVERSE EVENT REPORTED. CUSTOMER REPORTS SHE THREW OUT THE METER; A REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK COMPACT PLUS | BLOOD GLUCOSE MONITORING DEVICE-NBW | NBW | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | LANTUS 36 UNITS| JANUVIA DAILY| METFORMIN |