TRIAGE SOB PANEL
Received Apr 16, 2015 · Event occurred Jan 29, 2015
Report 2027969-2015-00284 · MDR key 4699391
Device
Product problems
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
OTHER PRODUCT CODES NOT LISTED: DAP, DDR, JHK, MMI. PRODUCT SUPPORT INVESTIGATED SOB LOT W58669B FOR DISCREPANT LOW COMPLAINT. ALL DEVICES RAN SUCCESSFULLY; NO ERRORS WERE OBSERVED. ALL DEVICES RETURNED VALUES WITHIN SPECIFICATION. THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED. THE ROOT CAUSE COULD NOT BE DETERMINED. THIS IS THE ONLY COMPLAINT FOR SOB LOT W58669B. NO PRODUCT DEFICIENCIES WERE ESTABLISHED; NO CORRECTIVE ACTION REQUIRED AT THIS TIME.
Description of Event or Problem
CUSTOMER IN (B)(6) REPORTED THAT THEY WERE OBSERVING VERY LOW RESULTS FOR CKMB WHEN COMPARING TRIAGE SOB TEST WITH THEIR LABORATORY ANALYZER. ALTHOUGH THE CUSTOMER INDICATED THAT THIS OCCURRED ON MANY SAMPLES, THERE WAS ONLY ONE SET OF DATA REPORTED. NO PATIENT INFORMATION WAS PROVIDED AND NO REPORT OF ANY ADVERSE EVENTS RELATED TO THESE FINDING.