FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA COMBO
MDR report key: 4102316
·
Received September 19, 2014
Report
- Report Number
- 1823260-2014-07182
- Event Type
- Malfunction
- Date Received
- September 19, 2014
- Date of Event
- August 25, 2014
- Report Date
- July 28, 2025
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K111353
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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
IT WAS REPORTED THAT THE PATIENT ALLEGES THE BOLUS RECOMMENDATIONS PROVIDED BY THE BLOOD GLUCOSE MONITOR ARE NOT ACCURATE. SHE EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS OVER 400 MG/DL. NO ADVERSE EVENT WAS REPORTED. THE BLOOD GLUCOSE METER WAS REQUESTED TO BE RETURNED, HOWEVER, THE BLOOD GLUCOSE MONITOR WAS MISPLACED BY THE PATIENT AND COULD NOT BE LOCATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584844 | ACCU-CHEK ® AVIVA COMBO | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |