FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® INFORM METER
MDR report key: 2152008
·
Received July 7, 2011
Report
- Report Number
- 1823260-2011-03637
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- June 21, 2011
- Report Date
- July 6, 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
UPON INVESTIGATION, MANUFACTURER'S DOMESTIC EVALUATIONS LAB FOUND EVIDENCE OF BURNED, MELTED ELECTRICAL CONTACT PINS AND MELTED PLASTIC AROUND INFORM METER ELECTRICAL CONTACT PINS. 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 |