FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 1011728
·
Received March 11, 2008
Report
- Report Number
- 1823260-2008-02305
- Event Type
- Malfunction
- Date Received
- March 11, 2008
- Date of Event
- February 22, 2008
- Report Date
- March 11, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES: 86 MG/DL, 429 MG/DL, AND 126 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK COMFORT CURVE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS - LFR | LFR | ROCHE DIAGNOSTICS | 549616 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | LEXAPRO 10MG 1/DAY - 2 YEARS| MAXZIDE 25MG 1/DAY - YEARS| OMEPRAZOLE 20MG 1/DAY - YEARS| ALBUTEROL AS NEEDED - YEARS| ADVAIR 250/50 INHALER 2/DAY - YEARS| "SPIRIDA" "INHALE CAPSULE" - YEARS| "BUSPIRONE-HC" 30MG 2/DAY - YEARS| CRESTOR 20MG 1/DAY - 2 YEARS| LISINOPRIL 10MG 1/DAY - 3 1/2 YEARS| THEOPHYLLINE 400MG 3/DAY - YEARS| DETROL-LA 4MG 1/DAY - 5 YEARS| "NORETHIN ACE" 5MG 1/DAY - 3 YEARS| LORATADINE 10MG 1/DAY - YEARS| GLIPIZIDE 10MG IN AM - 4-5 YEARS| METFORMIN 500MG 2TABS 2/DAY - 4-5 YEARS| POTASSIUM CHLORIDE 10MEQ - 2/DAY 2 YEARS| FUROSEMIDE 40MG 1/DAY - YEARS |