FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1924778
·
Received December 10, 2010
Report
- Report Number
- 2027969-2010-02144
- Event Type
- Malfunction
- Date Received
- December 10, 2010
- Date of Event
- November 11, 2010
- Report Date
- December 10, 2010
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, 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: 6.6, 5.0; LAB: 4.1. PT WAS RECENTLY HOSPITALIZED (BEFORE INR TEST). CUSTOMER CALLED TO REPORT AN ISSUE OBSERVED LAST WEEK BY ONE OF HER NURSES IN WHICH THEY TESTED A PT TWICE TO SEE RESULTS OF 6.6 AND 5.0. BOTH WERE DONE WITHIN MINUTES OF EACH OTHER. THE NURSE TOOK A VENOUS SAMPLE AND SENT IT TO THE LAB, PROCESSING TIME WAS UNK, SIMPLY DONE THAT SAME DAY. PT THERAPEUTIC RANGE: 2-3.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100139 | 235740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |