TRIAGE CARDIAC PANEL 25 TEST
Received Dec 4, 2014 · Event occurred Nov 19, 2014
Report 2027969-2014-01066 · MDR key 4346723
Device
Generic name
Cardiac Marker Test, Nbc, Ddr, Jhx, Mmi
Manufacturer
Alere San Diego, Inc.Model number
97000HSLot number
W58490B
Product problems
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION PENDING.
Description of Event or Problem
CUSTOMER REPORTED DISCREPANT LOW TROPONIN I (TNI) RESULT WITH THE TRIAGE VS. LAB ANALYZER. CUSTOMER REPORTED DISCREPANT LOW TNI RESULTS WITH THE TRIAGE CARDIAC PANEL VS. THE LAB ANALYZER. SAMPLES RUN AS WB EDTA ON THE TRIAGE; SERUM ON THE LAB ANALYZER. NO INFORMATION ON THE ORIGINAL CLINICAL PRESENTATION OF THE PATIENT. CUSTOMER DID NOT PERFORM SERIAL DRAWS OR DO ANY ADDITIONAL TESTING. SHE CANNOT PROVIDE THE FINAL OUTCOME OR WHETHER OR NOT ANY TREATMENTS OR INTERVENTIONS WERE PERFORMED, THOUGH SHE DID SAY THAT NOTHING WAS DONE BASED UPON THE TRIAGE RESULTS. PATIENT'S DIAGNOSIS: RAPID AFIB, STILL HOSPITALIZED AT TIME OF CALL.