FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ADVANTAGE
MDR report key: 1770963
·
Received November 13, 2007
Report
- Report Number
- 1823260-2007-09892
- Event Type
- Malfunction
- Date Received
- November 13, 2007
- Date of Event
- October 25, 2007
- Report Date
- November 13, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K930979
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
REPORTER ALLEGED, THE CUSTOMER OBTAINED A BLOOD GLUCOSE RESULT OF 681 MG/DL WHICH IS OUTSIDE THE READING RANGE OF 10-600 MG/DL OF THE ADVANTAGE SYSTEM. REPORTER ALSO STATED, THIS RESULT WAS OBTAINED AFTER AN ERROR MESSAGE OF E91 AND NEITHER THE ERROR MESSAGE NOR THE GLUCOSE READING COULD BE FOUND IN THE SYSTEM'S MEMORY. REPORTER INDICATED, THE CUSTOMER WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 | 83 YR | NORVASC - TIME UNK - 10MG ONCE DAILY| COLACE - TIME UNK - DOSAGE UNK| GLIPIZIDE - TIME UNK - 5MG ONCE DAILY| IRON - TIME UNK - 65MG ONCE DAILY| POTASSIUM - TIME UNK - 10MG ONCE DAILY| LASIX - TIME UNK - 10MG ONCE DAILY| COUMADIN - TIME UNK - 2MG EVERY OTHER DAY| LOPRESSOR - TIME UNK - 12.5MG TWICE DAILY| PRILOSEC - TIME UNK - 20MG ONCE DAILY| ASPIRIN - TIME UNK - DOSAGE UNK| ZOCOR - TIME UNK - 10MG ONCE DAILY |