FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK INFORM BASE
MDR report key: 1070108
·
Received July 3, 2008
Report
- Report Number
- 1823260-2008-05175
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- June 18, 2008
- Report Date
- July 3, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN ANOTHER COUNTRY.
Description of Event or Problem · 1
THE MANUFACTURER'S EVALUATION OF THE RETURNED INFORM BASE UNIT FOUND THAT THE DEVICE'S INTERNAL CONTACTS ARE BLACKENED AND MELTED. NO ASSOCIATED INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK INFORM BASE | BLOOD GLUCOSE MONITORING DEVICE- NA | NBW | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |