FDA Adverse Event
Malfunction
Summary report: N
INRATIO PT/INR TEST STRIP
MDR report key: 3897269
·
Received May 20, 2014
Report
- Report Number
- 2027969-2014-00472
- Event Type
- Malfunction
- Date Received
- May 20, 2014
- Date of Event
- April 24, 2014
- Report Date
- April 24, 2014
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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 PHYSICIAN'S METER. RESULTS AS FOLLOWS." DATE: (B)(6) 2014, INRATIO: 1.4, PHYSICIAN'S METER: 2.0. TESTING PERFORMED WITHIN MINUTES. THERAPEUTIC RANGE: 2.0-3.0. PATIENT SELF TESTER WAS USING ONE FINGERSTICK FOR MULTIPLE TESTS; FIRST DROP OF BLOOD NOT BEING USED. PATIENT SELF TESTER CALLED BACK ON (B)(6) 2014 AND HE RAN ANOTHER CORRELATION WITH POC METER VS. HIS INRATIO METER AND THEY AGREED. HE USED THE SAME LOT NUMBER OF STRIPS - (B)(4). HE HAS NO FURTHER CONCERNS AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299179 | INRATIO PT/INR TEST STRIP | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 335798 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MONITOR: SN (B)(4)| NO NEW MEDICATIONS| COUMADIN| NO RECENT CHANGES TO DAILY MEDICATIONS |