FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMPACT
MDR report key: 1761261
·
Received July 23, 2007
Report
- Report Number
- 1823260-2007-06427
- Event Type
- Malfunction
- Date Received
- July 23, 2007
- Date of Event
- July 10, 2007
- Report Date
- July 23, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K031755
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
CUSTOMER ALLEGED, BLOOD GLUCOSE ON THE COMPACT SYSTEM OF 354 MG/DL, ACCOMPANIED BY SYMPTOMS OF HIGH BLOOD GLUCOSE. CUSTOMER REPORTED SELF-TREATING WITH AVANDIA AND FELT BETTER WITHIN 2 HOURS. CUSTOMER ALLEGED THAT THE BLOOD GLUCOSE RESULT WAS STORED AS 175 MG/DL IN THE METER'S MEMORY. NO ADVERSE EVENT WAS REPORTED IN CONNECTION WITH THE MEMORY DISCREPANCY. 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 COMPACT | BLOOD GLUCOSE MONITORING DEVICE - NBW | NBW | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | SERTRALINE - 150MG DAILY| TOPAMAX - 50MG TWICE DAILY| HYDROXYZINE TAMOATE - 25MG 1-3 TIMES DAILY| SINGULAIR - 10MG DAILY| NEXIUM - 40MG TWICE DAILY| AVANDIA - 2 YEARS - 4MG DAILY| LYRICA - 75MG TWICE DAILY| PREMARIN - 0.625MG DAILY| ABILIFY - 10MG DAILY| LEVOTHYROXINE - 0.125MG DAILY| TRILEPTAL - 600MG TWICE DAILY| BUDEPRION XL - 300MG DAILY| FUROSEMIDE - 20MG DAILY| TOPROL XL - 25MG DAILY| SERTRALINE - 50MG DAILY |