FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 3070161
·
Received April 15, 2013
Report
- Report Number
- 2027969-2013-00296
- Event Type
- Malfunction
- Date Received
- April 15, 2013
- Date of Event
- December 5, 2012
- Report Date
- April 12, 2013
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
PT SELF TESTER ALLEGING OBSERVING LOW VALUES ON HER METER. ON (B)(6) 2013, INRATIO 1.6 REPEAT 2.0 TIME BETWEEN TESTING UNK. PT'S THERAPEUTIC RANGE 2.0 - 3.0. PT STATED SHE WAS NOT USING THE CORRECT STRIP CODE FOR THE LOT. THE PT INDICATED THAT HER DOSAGE HAS BEEN CHANGED BASED ON THE ABOVE RESULTS. THEY HAVE NOT HAD ANY LAB COMPARISONS DONE AGAINST THESE VALUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 160885 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100071 | 297451A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | JANUMET| METOPROLOL| SYMVASTATIN| DIGOXIN| SINGULAIR| THYROSIMIDE| ASPIRIN 81MG| GLIPIZIDE| COUMADIN |