TRIAGE PROFILER SOB PANEL
Received May 1, 2016 · Event occurred Mar 8, 2012
Report 2027969-2016-00267 · MDR key 5623020
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ADDITIONAL PRODUCT CODES: DAP, DDR, JHX, MMI. 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
THIS COMPLAINT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF CUSTOMER INTERACTION RECORDS AS PART OF AN INTERNAL ALERE (B)(4) CAPA (CAPA-(B)(4)) RELATED TO COMPLAINTS RECEIVED AT PARTICULAR ALERE INTAKE SITES THAT WERE NOT APPROPRIATELY FORWARDED TO ALERE (B)(4) FOR INVESTIGATION AND REPORTABILITY DETERMINATION. THE AVAILABLE INFORMATION IS LIMITED AND NO ADDITIONAL INFORMATION IS ABLE TO BE OBTAINED. THIS EVENT OCCURRED IN (B)(6). THE CUSTOMER REPORTED THAT A PATIENT PRESENTED TO THE OFFICE AND BLOOD WORK WAS PERFORMED AND SENT TO THE HOSPITAL. IN AN EFFORT TO KEEP THE PATIENT FROM WAITING LONG FOR THE LABORATORY RESULTS, A TRIAGE TESTING WAS PERFORMED. THE TROPONIN I RESULT WAS 0.35 (OK PER PHYSICIAN) IN ADDITION TO NORMAL MYOGLOBIN AND CK-MB. THE LABORATORY RESULTS SHOWED THAT THE PATIENT HAD A "HEART ATTACK." THERE WAS NO ADDITIONAL INFORMATION PROVIDED. (NOTE: THIS MDR FILING IS DUE TO THE DEVICE BEING THE SAME OR SIMILAR AS A DEVICE AVAILABLE IN THE UNITED STATES.)