FDA Adverse Event
Malfunction
Summary report: N
INRATIO PT/INR TEST STRIPS
MDR report key: 4152240
·
Received October 3, 2014
Report
- Report Number
- 2027969-2014-00908
- Event Type
- Malfunction
- Date Received
- October 3, 2014
- Date of Event
- September 22, 2014
- Report Date
- September 23, 2014
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
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) 2014; INRATIO: 1.6; LAB: 3.8. TIME BETWEEN TESTS: MINUTES. THERAPEUTIC RANGE: NOT PROVIDED BUT WIFE STATED HIS INR WAS USUALLY AROUND 3.0.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 617241 | INRATIO PT/INR TEST STRIPS | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 350587 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | ANTIBIOTIC: FOR A WEEK (NAME AND DOSAGE UNK)| COUMADIN| MONITOR: SN (B)(4)| ANTIBIOTIC: FOR A WEEK (NAME AND DOSAGE UNK)| COUMADIN| MONITOR: SN (B)(4) |