FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMPACT PLUS (GT)
MDR report key: 3040795
·
Received April 8, 2013
Report
- Report Number
- 1823260-2013-02136
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- March 11, 2013
- Report Date
- June 18, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
REPORTER ALLEGED THAT THE BATTERY LEAKED INSIDE DEVICE AND BURNED A HOLE THROUGH THE BACK OF THE METER. THE CUSTOMER STATED THAT 2-3 DAYS PRIOR TO THIS HE HAD DROPPED ONE OF THE BATTERIES WHEN HE CHANGED THEM. NO ADVERSE EVENT REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143121 | ACCU-CHEK ® COMPACT PLUS (GT) | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 030 YR |