KIT, TRIAGE, CARDIAC TNI/CKMB
Received Jul 29, 2016 · Event occurred Jun 30, 2016
Report 2027969-2016-00540 · MDR key 5833716
Device
Generic name
Cardiac Marker Test
Manufacturer
Alere San Diego, Inc.Model number
97022HSLot number
W61171RB
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
57 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION CONCLUSION: NO SAMPLE WAS RETURNED TO PRODUCT SUPPORT, FURTHER INVESTIGATION CANNOT BE PURSUED. UNABLE TO RULE OUT SAMPLE SPECIFIC INTERFERENCE AS A POTENTIAL CAUSE FOR DISCREPANT RESULTS. REVIEWED THE BATCH RECORD FOR LOT W61171. LOT MET ALL CARDIAC TNI/CKMB FINAL RELEASE SPECIFICATIONS. TRIAGE CARDIAC TNI/CKMB IS NOT CLAIMED TO CORRELATE WITH BECKMAN DXI ANALYZER. UNABLE TO DETERMINE ROOT CAUSE OF COMPLAINT. NO PRODUCT DEFICIENCY WAS ESTABLISHED.
Description of Event or Problem
EMAIL RECEIVED - CUSTOMER ALLEGING CRITICALLY HIGHER TNI ON TRIAGE CARDIAC TNI/CKMB IN THE EMERGENCY ROOM THAN THE HOSPITAL RETEST. PATIENT PRESENTED TO THE EMERGENCY ROOM FOR SHORTNESS OF BREATH AND CHEST PAIN. RESULT OF TNI ON TRIAGE: 0.11 NG/ML CKMB: 1.6 NG/ML; RETEST 0.09 NG/ML CKMB 1.7 NG/ML. PATIENT TRANSFERRED TO HOSPITAL WITH DX OF NON-STEMI, BASED UPON THE TRIAGE RESULTS OF ELEVATED TROPONIN. HOSPITAL ICU RETEST ON BECKMAN DXI. RESULTS OF RETEST ON BECKMAN DXI WERE NOT PROVIDED. REPORTEDLY THE TRIAGE RESULTS WERE CRITICALLY HIGHER. NO MEDICAL INTERVENTIONS WERE REPORTED BASED ON THE TRIAGE RESULT. CURRENT STATUS OF PATIENT AND ANY TREATMENT NOT PROVIDED BASED ON HIPPA. ADMISSION AND DISCHARGE DATE AND FINAL DISCHARGE DIAGNOSIS FOR PATIENT NOT PROVIDED DUE TO HIPPA.