FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® INFORM II METER
MDR report key: 4240353
·
Received November 10, 2014
Report
- Report Number
- 1823260-2014-08732
- Event Type
- Malfunction
- Date Received
- November 10, 2014
- Date of Event
- October 15, 2014
- Report Date
- November 24, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K012210
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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 THERE ARE ROUND BROWN SPOTS ON THE CHARGING CONTACTS OF THE INFORM II METER THAT LOOK BURNT. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICE, REPLACEMENT SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 722883 | ACCU-CHEK ® INFORM II METER | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |