FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2070755
·
Received April 14, 2011
Report
- Report Number
- 2027969-2011-00832
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Date of Event
- March 23, 2011
- Report Date
- April 14, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- 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
CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: PATIENT #2: DATE: (B)(6) 2011, INRATIO: 1.4, RETEST INRATIO: 3.1, PRETEST INRATIO: 3.3, LAB: 4.1, RETEST LAB: 4.2. FIRST INRATIO TEST DONE AT 11AM. THE 2 INRATIO RETESTS WERE DONE AT 3:15PM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 237431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |