FDA Adverse Event
Malfunction
Summary report: N
INRATIO2
MDR report key: 1972979
·
Received January 20, 2011
Report
- Report Number
- 2027969-2011-00148
- Event Type
- Malfunction
- Date Received
- January 20, 2011
- Date of Event
- December 30, 2010
- Report Date
- January 20, 2011
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- GJS
- PMA / PMN Number
- J072727
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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 REFERENCE. RESULTS AS FOLLOWS:" DATE: (B)(6) 2010; INRATIO: 2.6; REFERENCE, DOCTOR'S METER (MANUFACTURER UNKNOWN): 2.6. DATE: (B)(6) 2010; INRATIO: 1.4, 1.9, 1.6; REFERENCE, DOCTOR'S METER (MANUFACTURER UNKNOWN): 3.0. TODAY, PATIENT OBSERVED INR=1.4 WITH INRATIO, REPEATED TEST, INR=1.9. TESTED AT DOCTOR'S OFFICE WITH DOCTOR'S METER, INR=3.0. REPEATED TEST WITH INRATIO METER, INR=1.6. PREVIOUS INR RESULT ON (B)(6) 2010 = 2.6, WHICH CONFIRMED AT DOCTOR'S OFFICE WITH DOCTOR'S METER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100139 | 237431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |