FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 3050282
·
Received March 7, 2013
Report
- Report Number
- 2027969-2013-00194
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Date of Event
- January 9, 2013
- Report Date
- March 7, 2013
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT INRATIO RESULTS. RESULTS AS FOLLOWS: PATIENT 9, DATE: (B)(6) 2013, INRATIO: 1.3, REFERENCE: 2.83. PATIENT 10, (B)(6) 2013, 2.7, 1.46. PATIENT 16, (B)(6) 2013, 2.7, 7.39. PATIENT 22, (B)(6) 2013, 2.1, 5.76. PATIENT 29, (B)(6) 2013, 1.9, 6.36. PT #29 MAY HAVE BEEN TAKING ANTIBIOTICS. NO OTHER PT INFO WAS PROVIDED. ALL PTS WERE TESTED USING THE SAME STRIP LOT NUMBER, HOWEVER CUSTOMER WAS UNABLE TO PROVIDE THE NUMBER. CUSTOMER HAS 4 WINGS, EACH WITH ITS OWN METER AND STAFF. CUSTOMER IS NOT SURE WHICH METER WAS USED FOR WHICH PT. REFERENCE MDR #2027969-2013-00169, #2027969-2013-00193 AND #2027969-2013-00195 FOR ADDITIONAL METERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98459 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |