FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® INFORM METER
MDR report key: 2882059
·
Received December 20, 2012
Report
- Report Number
- 1823260-2012-06451
- Event Type
- Malfunction
- Date Received
- December 20, 2012
- Date of Event
- November 28, 2012
- Report Date
- December 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
- MI, 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
THE CUSTOMER REPORTED A BURNED ELECTRICAL CONTACT PIN, REPORTED "SHE SMELLS BURNING". UPON INVESTIGATION, MANUFACTURER'S DOMESTIC EVALUATIONS LAB FOUND SIGNS OF MELTING AND BURNING PRESENT ON THE INFORM METER. ELECTRICAL CONTACT PINS ARE BURNED, PLASTIC OF THE CASE AROUND INFORM METER ELECTRICAL CONTACT PINS IS MELTED. NO ADVERSE EVENT REPORTED. THE DEVICE WAS RETURNED, REPLACEMENT SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® INFORM METER | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |