TRIAGE CARDIAC TRIPLE MARKER PANEL
Received Nov 30, 2016 · Event occurred Nov 10, 2016
Report 2027969-2016-00697 · MDR key 6135711
Device
Generic name
Cardiac Marker Test
Manufacturer
Alere San Diego, Inc.Model number
97000HSEULot number
W62034RB
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION CONCLUSION: INVESTIGATION PENDING.
Description of Event or Problem
REPORT RECEIVED OF DISCREPANT RESULTS FOR TROPONIN I AT A PATIENT CLINIC. EVENT OCCURRED IN (B)(6). PATIENT # 2 BELOW HAD A POSITIVE RESULT FOR TROPONIN I, BUT THE FOLLOW WAS A NEGATIVE RESULT. ON (B)(6) 2016 08:07 RESULT: 0.7 CPK:120 CKMB: 13. ON (B)(6) 2016 21:40 RESULT: <0.05 CPK:102 CKMB: 10. ECG NORMAL PARAMETERS. OPTIC CHECK OK . NO REPORTED ADVERSE PATIENT SEQUELA. THIS DISCORDANT RESULTS ONLY APPEAR FOR TROPONIN I. THE OTHER CARDIAC ENZYMES RESULTS WERE COHERENT WITH PATIENT CLINIC. NO ADDITIONAL INFORMATION PROVIDED.
Additional Manufacturer Narrative
INVESTIGATION/CONCLUSION: CUSTOMER'S COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT W62034. NO ISSUES WITH TNI RECOVERY WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT W62034 WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATIONS. FURTHER INVESTIGATION WAS NOT POSSIBLE SINCE THE CUSTOMER DID NOT RETURN ANY SAMPLES FOR TESTING. UNABLE TO DETERMINE A ROOT CAUSE FROM THE AVAILABLE INFORMATION. PRODUCT DEFICIENCY WAS NOT ESTABLISHED.