FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ADVANTAGE
MDR report key: 1770609
·
Received October 25, 2007
Report
- Report Number
- 1823260-2007-09307
- Event Type
- Malfunction
- Date Received
- October 25, 2007
- Date of Event
- October 13, 2007
- Report Date
- October 25, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K930979
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTEDLY OBTAINED A RESULT OF >900 MG/DL ON THE ADVANTAGE METER. THE DEVICE'S NUMERIC READING RANGE IS 10-600 MG/DL. NO ACTION TAKEN ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. RESULT NOT FOUND IN DEVICE MEMORY. REQUESTED RETURN OF SUSPECT DEVICE AND A REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ADVANTAGE | BLOOD GLUCOSE MONITORING DEVICE - NBW | NBW | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | LOSARTIN - 1 YEAR, 12.5 MG/DAY| METFORMIN - YEARS, 2000 MG/DAY| GLYBURIDE - YEARS, 20 MG/DAY |