MalfunctionNBC
TRIAGE CARDIAC PANEL 25 TEST
Received Dec 9, 2014 · Event occurred Nov 21, 2014
Report 2027969-2014-01071 · MDR key 4339851
Device
Generic name
Cardiac Marker Test
Manufacturer
Alere San Diego, Inc.Model number
97000HSLot number
W58525B
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 TRIAGE TROPONIN I (TNI) RESULT VS. LAB ANALYZER. CUSTOMER OBSERVED A DISCREPANT LOW TROPONIN I RESULT WITH THE TRIAGE CARDIAC PANEL WHEN COMPARED TO THE LAB ANALYZER. THERE IS NO INFORMATION ON THE ORIGINAL CLINICAL PRESENTATION OF THE PATIENT. IT WAS NOTED THAT THE PATIENT WAS NOT TREATED BASED UPON THE TRIAGE RESULT. PATIENT'S DIAGNOSIS: FLUID IN THE LUNGS; NO FURTHER INFORMATION AVAILABLE.