FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® INFORM
MDR report key: 1980089
·
Received February 7, 2011
Report
- Report Number
- 1823260-2011-00633
- Event Type
- Malfunction
- Date Received
- February 7, 2011
- Date of Event
- January 21, 2011
- Report Date
- February 11, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K012210
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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 A PIN IN CONNECTOR PORT OF THIS INFORM METER LOOKS BURNT AND BLACK PLASTIC AROUND CONNECTOR PORT APPEARS MELTED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER, REPLACEMENT SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® INFORM | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |