FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® INFORM METER
MDR report key: 2143119
·
Received June 28, 2011
Report
- Report Number
- 1823260-2011-03494
- Event Type
- Malfunction
- Date Received
- June 28, 2011
- Date of Event
- June 10, 2011
- Report Date
- June 28, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
CALLER REPORTED "CHARRED" CONTACTS ON THE INFORM METER. NO ADVERSE EVENT REPORTED. MANUFACTURER'S FIRST LEVEL INVESTIGATION CONFIRMED MELTING, BURNING AND CORROSION ON THE CONTACTS OF THE INFORM METER. REPLACEMENT WAS 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 |