FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK ® AVIVA
MDR report key: 1904733
·
Received November 22, 2010
Report
- Report Number
- 1823260-2010-06857
- Event Type
- Injury
- Date Received
- November 22, 2010
- Date of Event
- November 11, 2010
- Report Date
- February 16, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K043474
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER WAS UNABLE TO OBTAIN THIS INFORMATION FROM THE CALLER.
Description of Event or Problem · 1
CALLER REPORTS BEING UNABLE TO OBTAIN A RESULT DUE TO AN ERROR ON THE AVIVA SYSTEM WHILE CUSTOMER WAS HAVING LOW BLOOD GLUCOSE SYMPTOMS. CUSTOMER WAS TREATED WITH A CANDY BAR, SANDWICH, AND ORANGE JUICE. CUSTOMER'S LOW BLOOD GLUCOSE SYMPTOMS IMPROVED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® AVIVA | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |