KIT, TRIAGE, CARDIAC TNI/CKMB
Received Jul 29, 2016 · Event occurred Jun 29, 2016
Report 2027969-2016-00539 · MDR key 5833723
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
36 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
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. ON (B)(6) 2016 PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SHORTNESS OF BREATH AND CHEST PAIN. RESULT OF TNI ON TRIAGE WAS 0.68 NG/ML CKMB: 4.6 NG/ML. DUE TO THE ELEVATED TROPONIN, THE PATIENT WAS TRANSFERRED TO THE HOSPITAL ICU. PATIENT ADMITTED TO THE HOSPITAL FOR "END STEMI". HOSPITAL ICU RETESTED PATIENT ON BECKMAN DXI. IT WAS REPORTED THE TRIAGE RESULTS WERE CRITICALLY HIGHER THAN THE BECKMAN TEST RESULTS. RESULTS OF THE RETEST ON BECKMAN DXI WERE NOT OBTAINABLE, DUE TO HIPPA . NO INTERVENTIONS WERE REPORTED BASED ON THE TRIAGE RESULTS. UNABLE TO OBTAIN CURRENT STATUS OF PATIENT DUE TO HIPPA. ADMISSION AND DISCHARGE DATE AND FINAL DISCHARGE DIAGNOSIS OF PATIENT WAS NOT PROVIDED.