FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK ADVANTAGE
MDR report key: 1020033
·
Received March 27, 2008
Report
- Report Number
- 1823260-2008-02831
- Event Type
- Injury
- Date Received
- March 27, 2008
- Date of Event
- March 9, 2008
- Report Date
- March 27, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- CGA
- PMA / PMN Number
- K930979
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTS BEING UNABLE TO TEST HER BLOOD GLUCOSE FOR 2 DAYS ON THE ADVANTAGE SYSTEM BECAUSE OF POWER ISSUE. CUSTOMER REPORTS ON THE DAY OF THE INCIDENT SHE ATTEMPTED TO TEST HER BLOOD GLUCOSE WHILE HAVING HIGH BLOOD SYMPTOMS, BUT WAS UNABLE TO OBTAIN A RESULT (STATES SHE WOULD HAVE TREATED HERSELF WITH INSULIN SHE HAD KNOWN THE RESULT). SHE WAS TAKEN TO THE HOSPITAL AND ADMITTED FOR HIGH BLOOD AND CONGESTIVE HEART FAILURE. CUSTOMER WAS RELEASED FROM THE HOSPITAL 5 DAYS LATER. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ADVANTAGE | BLOOD GLUCOSE MONITORING DEVICE - CGA | CGA | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization | NOVOLIN 70/30 10 UNITS PM - APPROX 25 YEARS| NOVOLIN 70/30 40 UNITS AM - APPROX 25 YEARS |