FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHECK COMFORT CURVE TEST STRIPS
MDR report key: 1022632
·
Received March 31, 2008
Report
- Report Number
- 1823260-2008-02865
- Event Type
- Malfunction
- Date Received
- March 31, 2008
- Date of Event
- March 24, 2008
- Report Date
- March 31, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS MEDWATCH IS FOR THE SUSPECT DEVICE USED IN INFORM SYSTEM #1. PLEASE SEE MEDWATCH WITH PT IS FOR SUSPECT DEVICE IN INFORM #2.
Description of Event or Problem · 1
CALLER REPORTS BACK TO BACK RESULTS OF 532 MG/DL ON INFORM SYSTEM #1 COMPARED TO RESULTS OF 176 MG/DL ON INFORM SYSTEM #2. CALLER REPORTS PT WAS TREATED BASED ON METER #2 RESULTS OF 176 MG/DL; TREATMENT WAS NOT PROVIDED. CALLER REPORTS QUALITY CONTROLS WERE RUN AND IN RANGE. NO ADVERSE EVENT REPORTED. CALLER REPORTS THERE ARE NO STRIPS TO RETURN; A REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHECK COMFORT CURVE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS - LFR | LFR | ROCHE DIAGNOSTICS | 550528 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | GLYBURIDE - 2.5MG AM| COUMADIN - 5MG DAILY| NOVOLOG SLIDING SCALE AC/HS| KEPPRA - 500MG 2X/DAY| MULTIVITAMIN - DAILY| FOLIC ACID - 1 MG DAILY| SEROQUEL - 100MG 3X/DAY| CARAFATE - 1G 3X/DAY| LOPRESSOR - 12.5MG 2X/DAY |