FDA Adverse Event
Malfunction
Summary report: N
TRIAGE D-DIMER TEST
MDR report key: 2544967
·
Received April 18, 2012
Report
- Report Number
- 2027969-2012-00535
- 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 FALSE NEGATIVE D-DIMER RESULTS WITH 3 SAMPLES WHILE RUNNING A PLASMA TO WHOLE BLOOD CORRELATION STUDY: SAMPLE NUMBER: (B)(6), PLASMA: 599, WHOLE BLOOD: 296. SAMPLE NUMBER: (B)(6), PLASMA: 444, WHOLE BLOOD: 252. SAMPLE NUMBER: (B)(6), PLASMA: 481, WHOLE BLOOD: 254. CUSTOMER USES A CUTOFF OF 400 TO DETERMINE POSITIVE D-DIMER RESULTS: THIS CORRELATION STUDY WAS RUN USING 2 TRIAGE METERS. RESULTS FROM THE OTHER METER (NUMBER 66704) HAVE BEEN REPORTED ON MDR NUMBER 2027969-2012-00534.
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 |