FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® INFORM METER
MDR report key: 2840981
·
Received November 20, 2012
Report
- Report Number
- 1823260-2012-05912
- Event Type
- Malfunction
- Date Received
- November 20, 2012
- Date of Event
- October 25, 2012
- Report Date
- November 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
- IN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
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 |