FDA Adverse Event
Malfunction
Summary report: N
TRIAGE D-DIMER TEST
MDR report key: 2544968
·
Received April 18, 2012
Report
- Report Number
- 2027969-2012-00534
- Event Type
- Malfunction
- Date Received
- April 18, 2012
- Date of Event
- March 26, 2012
- Report Date
- April 18, 2012
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJA
- PMA / PMN Number
- K042890
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CUSTOMER ALLEGES (B)(6) D-DIMER RESULTS WITH 3 SAMPLES WHILE RUNNING A PLASMA TO (B)(4) STUDY: SAMPLE NUMBER: 8310, PLASMA: 501, WHOLE BLOOD: 280. SAMPLE NUMBER: 8325, PLASMA: 446, WHOLE BLOOD: 232, SAMPLE NUMBER: 8232, PLASMA: 471, WHOLE BLOOD: 232. CUSTOMER USES A CUTOFF OF 400 TO DETERMINE POSITIVE D-DIMER RESULTS. THIS (B)(4) STUDY WAS RUN USING 2 TRIAGE METERS. RESULTS FROM THE OTHER METER (B)(4) HAVE BEEN REPORTED ON MDR NUMBER 2027969-2012-000535.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIAGE D-DIMER TEST | CARDIAC MARKER TEST | GJA | ALERE SAN DIEGO, INC. | 98100 | W50551B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |