FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1811223
·
Received August 11, 2010
Report
- Report Number
- 2027969-2010-01182
- Event Type
- Malfunction
- Date Received
- August 11, 2010
- Date of Event
- July 14, 2010
- Report Date
- August 11, 2010
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- GJS
- PMA / PMN Number
- 021923
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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. RESULTS AS FOLLOWS: CUSTOMER RUNS ABOUT 140 TESTS A MONTH. CUSTOMER CALLED BACK AND RECEIVED THE FOLLOWING VALUES WITH NEW STRIP LOT (234586):
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100139 | 232887 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |