FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® INFORM METER
MDR report key: 3223686
·
Received July 12, 2013
Report
- Report Number
- 1823260-2013-04225
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Date of Event
- June 21, 2013
- Report Date
- September 18, 2013
- 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 REPORTED THE SCREEN OF THE INFORM METER LOOKS LIKE IT HAS A MELTED PORTION ON THE OUTSIDE. SHE CLAIMS IT APPEARS THE METER HAS GOTTEN HOT ON THE SCREEN. SHE CAN'T CONFIRM WHETHER FROM METER OR AN OUTSIDE HEAT SOURCE. SHE DOES CLAIM IT APPEARS THE HEAT CAME FROM OUTSIDE, AND NOT INSIDE, THE METER. A REQUEST WAS MADE FOR THE RETURN OF THE METER, REPLACEMENT SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322435 | ACCU-CHEK ® INFORM METER | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |