FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK AVIVA
MDR report key: 1213860
·
Received October 28, 2008
Report
- Report Number
- 1823260-2008-07947
- Event Type
- Injury
- Date Received
- October 28, 2008
- Date of Event
- October 9, 2008
- Report Date
- October 28, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K043474
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTED AN INCIDENT OF HYPERGLYCEMIA, REQUIRING HOSPITALIZATION AT A TIME WHEN HE WAS UNABLE TO USE HIS AVIVA SYSTEM, DUE TO ERROR WITHIN SPECIFICATIONS. THE CUSTOMER TESTED SUCCESSFULLY AT 9:52 PM, WAS UNABLE TO TEST THE NEXT MORNING, WAS HOSPITALIZED AT 12:30 PM, TREATED FOR HYPERGLYCEMIA. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK AVIVA | BLOOD GLUCOSE MONITORING DEVICE - NBW | NBW | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Hospitalization| R | HYDROCHLOROTHIAZIDE| LANTUS| NOVOLIN SLIDING SCALE - 1 YEAR| METOPROLOL| HYDRALAZINE| LISINOPRIL |