FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT TEST STRIPS
MDR report key: 862417
·
Received March 28, 2007
Report
- Report Number
- 1823260-2007-02482
- Event Type
- Malfunction
- Date Received
- March 28, 2007
- Date of Event
- February 18, 2007
- Report Date
- March 28, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- k010362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
SUSPECT DEVICE: COMFORT CURVE TEST STRIPS.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY OBTAINED RESULTS OF 470MG/DL AND 162MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE TEST SYSTEM. AT A LATER TIME, CUSTOMER REPORTEDLY OBTAINED RESULTS OF 108MG/DL AND 236MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE TEST SYSTEM. NO ACTION TAKEN BASED ON THE DEVICE RESULTS. NO ADVERSE EVENT REPORTED. NO INFO GIVEN ON WHERE COMPARISON OCCURRED. REQUESTED RETURN OF SUSPECT TEST SYSTEM AND REPLACEMENT WAS SENT. ADVANTAGE TEST SYSTEM: METER, TEST STRIP LOT 549430, EXP 01/31/2008, CAT/2030381.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK COMFORT TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS - LFR | LFR | ROCHE DIAGNOSTICS | * | 549430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | EPZICOM - 4 MHTS, 600MG/1XDAY| LISINOPRIL/HCTZ - 2 YEARS, MG UNK/1XDAY| GLYBURIDE - 5MG/2XDAY| OMEGA3 - 5 YEARS, MG UNK/2XDAY| LIPITOR - 5 YEARS, 40MG/1XDAY| VITAMIN E - 10YEARS, 400IU/1XDAY| OCUTABS - 5 YEARS, 1000U/1XDAY| VITAMIN C -10 YEARS, 1000MG/1XDAY| REYATAZ - 2-3 MONTHS, 150MG/1XDAY| LEXIVA - 2 MTHS, 700MG/1X DAY| ASPIRIN - 81MG/1XDAY| GABAPENTIN - 2 MONTHS, 300 MG/1XDAY| NORVIR - 5 YEARS, 100MG/1XDAY| HUMULIN - 6 MONTHS/SLIDING SCALE| TRUVADA - 5 YEARS, MG UNK/1XDAY| COENZYME Q-10 - 2 YEARS, 50MG/1XDAY| LANTUS - 1 YEAR/SLIDING SCALE| AVANDIA - 1 YEAR, 4MG/2XDAY |