FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® PERFORMA COMBO
MDR report key: 4222647
·
Received November 4, 2014
Report
- Report Number
- 1823260-2014-08492
- Event Type
- Malfunction
- Date Received
- November 4, 2014
- Date of Event
- December 1, 2013
- Report Date
- August 12, 2025
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A LINE GOING ACROSS THE DISPLAY OF THE BLOOD GLUCOSE MONITOR. NO ADVERSE EVENT WAS REPORTED. THE BLOOD GLUCOSE MONITOR WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 705727 | ACCU-CHEK ® PERFORMA COMBO | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Female |