FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK ® AVIVA
MDR report key: 2000485
·
Received February 24, 2011
Report
- Report Number
- 1823260-2011-01019
- Event Type
- Injury
- Date Received
- February 24, 2011
- Date of Event
- February 9, 2011
- Report Date
- March 17, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K043474
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CALLER REPORTED AN INCIDENT OF HYPOGLYCEMIA REQUIRING TREATMENT BY LAYPERSON AT A TIME WHEN THE AVIVA METER WAS UNAVAILABLE FOR USE DUE TO ERROR WITHIN SPECIFICATIONS. CALLER WAS ABLE TO PROVIDE THE CUSTOMER WITH CANDY BAR AND SERVERAL GLASSES OF JUICE. CUSTOMER STARTED FEELING BETTER. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM AND A 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 | 078 YR | Required Intervention | PRANDIN |