FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA EXPERT
MDR report key: 3955871
·
Received July 24, 2014
Report
- Report Number
- 1823260-2014-05529
- Event Type
- Malfunction
- Date Received
- July 24, 2014
- Date of Event
- June 29, 2014
- Report Date
- July 28, 2025
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PATIENT
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CALLER STATES THAT THE EXPERT METER "IS MELTING UNDER THE SCREEN IN THE LOWER RIGHT HAND CORNER". NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 433521 | ACCU-CHEK ® AVIVA EXPERT | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |