FDA Adverse Event
Malfunction
Summary report: N
INRATIO2
MDR report key: 2243821
·
Received July 29, 2011
Report
- Report Number
- 2027969-2011-01688
- Event Type
- Malfunction
- Date Received
- July 29, 2011
- Date of Event
- June 23, 2011
- Report Date
- July 29, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- 072727
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 LAB. CALLER ALSO REPORTED IMPRECISION WITH INRATIO METER. PT'S THERAPEUTIC RANGE: 2.5-3.5 INR. PT BEGAN USING THE INRATIO METER IN (B)(6) 2010 AND HAD NO PROBLEMS UNTIL A HOSPITAL STAY THAT ENDED ON (B)(6) 2011. A NEW BOX OF STRIPS (LOT# 247451) WAS USED FOR ALL TESTS PERFORMED AFTER (B)(6) 2011. THE ORIGINAL BOX WAS TOSSED OUT AND LOT NUMBER IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO2 | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 247451 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |