FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE
MDR report key: 725984
·
Received February 6, 2006
Report
- Report Number
- 1823260-2006-00488
- Event Type
- Malfunction
- Date Received
- February 6, 2006
- Date of Event
- December 20, 2005
- Report Date
- January 13, 2006
- Manufacturer
- *
- Product Code
- LFR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REPORTER ALLEGED HIGH BLOOD GLUCOSE DEVICE READINGS OF 240-383 MG/DL. IT WAS REPORTED METER READ IN THE 300S MG/DL AND A DIFFERENT METER READ 199MG/DL FIVE MINUTES LATER. REPORTER STATED METER READ 286MG/DL WHILE A FASTING MEASURED 115MG/DL. REPORTER INDICATED ADJUSTING INSULIN DOSAGE BASED ON THE HIGHER READINGS. HOWEVER, NO MEDICAL TREATMENT WAS REPORTEDLY RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT PRODUCT. HOWEVER, NO PRODUCT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK COMFORT CURVE | BLOOD GLUCOSE MONITORING SYSTEM | LFR | * | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | ACCU-CHEK COMFORT CURVE CONTROLS| "PROLISET"| "PROLISET"| SYNTHROID| HUMULIN H| ACCU-CHEK ADVANTAGE METER |