FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® INFORM BASE
MDR report key: 2841032
·
Received November 20, 2012
Report
- Report Number
- 1823260-2012-05914
- Event Type
- Malfunction
- Date Received
- November 20, 2012
- Date of Event
- October 30, 2012
- Report Date
- November 20, 2012
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K012210
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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 STATES THAT THE INFORM METER SHOWED SIGNS OF MELTING AND BURNING ON THE BOTTOM OF THE BASE. THERE IS BURNT PLASTIC AROUND THE CONNECTOR PINS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® INFORM BASE | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |