MalfunctionJHF
TRIAGE PROFILER SOB 25 TEST KIT
Received Jun 29, 2009 · Event occurred Jun 8, 2009
Report 2027969-2009-00511 · MDR key 1462133
Device
Generic name
Cardiac Marker Test
Manufacturer
Biosite IncorporatedModel number
97300Catalog number
97300
Lot number
W43951
Product problems
- False Negative Result
Patient
NI
- No Information
Narrative
Description of Event or Problem
CUSTOMER IS HAVING CORRELATION ISSUES (FALSE NEGATIVE RESULT) FOR CKMB WHEN TESTING TRIAGE PROFILER SOB 25 TEST KIT ON TRIAGE METER VS. LAB CORP. CUSTOMER DOING CORRELATION STUDY FOR SOB AND RECEIVED DISCREPANT RESULTS. SOME RESULTS FOR CKMB ARE NEGATIVE USING TRIAGE METER AND ARE POSITIVE USING LAB CORP. CUT OFF FOR CKMB FOR TRIAGE S 4.3 AND CUT OFF FOR LAB CORP IS 2.9. NO CLINICAL INFO PROVIDED FOR PT AND CORRELATION WAS RUN USING MULTIPLE LOTS.
Additional Manufacturer Narrative
INVESTIGATION PENDING.
Remedial action
- Other