FDA Adverse Event
Malfunction
Summary report: N
INRATIO PT/INR TEST STRIP
MDR report key: 3874852
·
Received April 25, 2014
Report
- Report Number
- 2027969-2014-00373
- Event Type
- Malfunction
- Date Received
- April 25, 2014
- Date of Event
- April 4, 2014
- Report Date
- April 11, 2014
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, 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: 3.0. LAB: 2.15. INRATIO WAS TESTED LESS THAN TWO HOURS AFTER LAB DRAW WAS PERFORMED. THERAPEUTIC RANGE: 2.5 - 3.5. PT SELF TESTER IS (B)(6) YEARS OLD. HIS MOTHER STATED THAT COUMADIN WAS INCREASED BASED ON THE INRATIO, BUT IT WOULD HAVE BEEN INCREASED BASED ON THE LAB AS WELL. MILKING OF FINGER AFTER FINGERSTICK; TOUCHING FINGER TO SAMPLE WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250464 | INRATIO PT/INR TEST STRIP | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 334579 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Male | COUMADIN.| HEART MEDICATIONS - NO RECENT CHANGES. | METER SERIAL # (B)(4)| HEART MEDICATIONS - NO RECENT CHANGES.| METER SERIAL # (B)(4)| COUMADIN. |