FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK COMFORT CURVE
MDR report key: 418953
·
Received September 17, 2002
Report
- Report Number
- 1823260-2002-00306
- Event Type
- Injury
- Date Received
- September 17, 2002
- Date of Event
- September 2, 2002
- Report Date
- September 5, 2002
- Manufacturer
- ROCHE DIAGNOSITCS
- Product Code
- LFR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE PATIENT USED THE SUSPECT DEVICE TO CHECK THEIR BLOOD GLUCOSE AND OBTAINED A RESULT OF 115 MG/DL. ABOUT ONE HOUR LATER PT HAD TO GO TO THE HOSPITAL AND THEIR GLUCOSE WAS 34 MG/DL UPON ARRIVAL. PT WAS GIVEN AN IV AND KEPT OVERNIGHT. LEVEL 2 GLUCOSE CONTROL WAS RUN ON THE SYSTEM AND THE CONTROL RESULT WAS OUT OF RANGE. THE SUSPECT DEVICE WAS REPLACED WITH NEW PRODUCT AND THEN AUTHORIZED FOR RETURN TO THE MANUFACTURER FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK COMFORT CURVE | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSITCS | NA | 545696 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |