FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1853658
·
Received September 30, 2010
Report
- Report Number
- 2027969-2010-01623
- Event Type
- Malfunction
- Date Received
- September 30, 2010
- Date of Event
- August 4, 2010
- Report Date
- September 30, 2010
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
"CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS". DATE : (B)(6) 2010, INRATIO: 1.7, LAB: 1.4. CUSTOMER REPORTED DISCREPANT RESULTS WITH THEIR METER. SAID THAT IT HAPPENED IN 3-4 PATIENTS TOTAL, BUT ONLY HAD RESULTS FOR ONE PT. CHART WAS NOT AVAILABLE, BUT PT WAS ON (OR JUST FINISHED) LOVENOX BRIDGING THERAPY. NOT SURE HOW LONG PT HAD BEEN TAKING COUMADIN OR IF LEVELS WERE STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 230792 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |