TRIAGE CARDIAC TRIPLE MARKER PANEL
Received Dec 7, 2015
Report 2027969-2015-00987 · MDR key 5271064
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION CONCLUSION: FURTHER INVESTIGATION CANNOT BE PURSUED BECAUSE THERE IS NO LOT NUMBER/SERIAL NUMBER AND PRODUCT WAS NOT RETURNED.
Description of Event or Problem
NURSE CALLED REPORTING DISCREPANT LOW TNI WITH ONE PATIENT; TRIAGE TNI=0.07 AND VITROS TNI=0.18. NURSE UNABLE TO PROVIDE DETAILS AT THE TIME OF CALL. TRIAGE TNI=0.07 (CUT-OFF=0.05) SAMPLE COLLECTED INTO EDTA TUBE, RUNNING WB. VITROS TNI=0.18 (UNKNOWN CUT-OFF) SAMPLE COLLECTED INTO LITHIUM HEPARIN TUBE. CUSTOMER UNABLE TO PROVIDE DATE OF OCCURRENCE. SAMPLES COLLECTED AT APPROXIMATELY THE SAME TIME. SAMPLES THAT ARE "POSITIVE" ON THE TRIAGE METER ARE IMMEDIATELY DRAWN AND SENT TO THE LAB (VITROS). SAMPLES THAT ARE FLAGGED ABNORMAL ON THE TRIAGE METER ARE IMMEDIATELY SENT TO THE LAB FOR CONFIRMATORY TESTING. PATIENT ADMITTED TO THE HOSPITAL - NO ADDITIONAL INFORMATION PROVIDED. ALTHOUGH REQUESTED NUMEROUS TIMES, NO ADDITIONAL INFORMATION PROVIDED REGARDING PATIENT, DATE OF OCCURRENCE, LOT NUMBER OR HOSPITALIZATION.