FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK S SYSTEM
MDR report key: 792009
·
Received November 28, 2006
Report
- Report Number
- 1823260-2006-06943
- Event Type
- Malfunction
- Date Received
- November 28, 2006
- Date of Event
- November 1, 2006
- Report Date
- November 28, 2006
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JPA
- PMA / PMN Number
- K974569
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL STRIP LOT USED: 377A D4, 2007-12, INTERNATIONAL TEST STRIPS.
Description of Event or Problem · 1
CALLER STATES THAT, THE DEVICE READ 8.0 INR AND 7.9 INR DURING DUPLICATE TESTING WHILE A LAB RESULT READ 5.39 INR. COMPARISON WAS REPORTEDLY PERFORMED WITHIN 15 MINUTES. CALLER IS UNSURE WHICH STRIP LOT PRODUCED EACH RESULT. NO ACTION WAS 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 | COAGUCHEK S SYSTEM | PROTHROBMIN TIME TEST STRIPS JPA | JPA | ROCHE DIAGNOSTICS | * | 360A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | BENICAR HCT NP 20/12.5 MG/1X| ZOCOR NP 40MG/1X| COUMADIN NP 5MG/1X |