TRIAGE CARDIAC TRIPLE MARKER PANEL
Received Jan 29, 2016 · Event occurred Jan 21, 2016
Report 2027969-2016-00060 · MDR key 5399523
Device
Product problems
- False Positive Result
- Incorrect, Inadequate or Imprecise Result or Readings
- False Positive Result
- 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
PRODUCT CODE (CONTINUED): DDR, JHX AND MMI INVESTIGATION/CONCLUSION: THE CUSTOMER DID NOT PROVIDE A LOT NUMBER OR RETURN ANY PRODUCTS FOR INVESTIGATION. SINCE THE PRODUCT(S) ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED AND A LOT NUMBER WAS NOT PROVIDED, MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED AND FURTHER INVESTIGATION WAS NOT POSSIBLE. ALL COMPLAINTS ARE TRACKED AND MONITORED.
Description of Event or Problem
ON (B)(6) 2016, AN EMAIL WAS RECEIVED FROM THE CUSTOMER QUESTIONING TRIAGE CK-MB AND MYOGLOBIN RESULTS ON (B)(6) 2016. THE RESULTS ARE AS FOLLOWS: (B)(6). THERE WERE NO REPORTED ADVERSE EVENTS RELATED TO THE TRIAGE RESULTS. THOUGH REQUESTED, THE ONLY INFORMATION THE CUSTOMER WAS ABLE TO PROVIDE REGARDING THE PATIENT WAS THAT THE ELECTROCARDIOGRAM (EKG) AND CHEST X-RAY WERE NEGATIVE AND THE PATIENT WAS DISCHARGED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.