FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® INFORM BASE
MDR report key: 2925174
·
Received January 22, 2013
Report
- Report Number
- 1823260-2013-00383
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Date of Event
- December 23, 2012
- Report Date
- January 22, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K012210
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CALLER REPORTED THE INFORM BASE WAS FOUND SMOKING. THE PLASTIC OF THE BASE HAS BLACK FIRE MARKS, CONNECTOR PINS ARE BURNT, AND THE PLASTIC IS MELTED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE BASE, REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30876 | ACCU-CHEK ® INFORM BASE | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |