TRIAGE PROFILER SOB PANEL
Received Nov 21, 2016 · Event occurred Oct 26, 2016
Report 2027969-2016-00686 · MDR key 6119121
Device
Generic name
Cardiac Marker Test
Manufacturer
Alere San Diego, Inc.Model number
97300EULot number
W62069B
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
37 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION CONCLUSION: CUSTOMER'S COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT W62069. NO ISSUES WITH CKMB RECOVERY OBSERVED. REVIEWED THE BATCH RECORD FOR LOT W62069. LOT MET ALL OUS FINAL RELEASE SPECIFICATIONS. UNABLE TO DETERMINE ROOT CAUSE OF COMPLAINT. PRODUCT DEFICIENCY WAS NOT ESTABLISHED.
Description of Event or Problem
EVENT OCCURRED IN (B)(6). CUSTOMER ALLEGING TRIAGE PROFILER SOB PANEL HAD DISCREPANT RESULTS WITH CK-MB IN COMPARISON TO THE RESULTS FROM THE HOSPITAL LABORATORY. TRIAGE CK MB RESULT 33,3 ( SHOULD BE WITHIN 0-4,3) AND IN THE HOSPITAL AFTER VENOUS BLOOD SAMPLE IT WAS 17,6 AND IT SHOULD BE LESS THAN 24. NO REPORTED ADVERSE PATIENT SEQUELA.