Description of Event or Problem · 1
FALSE POSITIVE COVID RESULTS REPORTED FOR 29 PTS AS A RESULT OF A FLAW IN THE MFR'S INTERPRETIVE SOFTWARE, (B)(4) ON (B)(6) 2020, (B)(6) LABORATORY SCIENTIST REPORTED TO THERMO FISHER SCIENTIFIC THAT REPEATED ATTEMPTS TO RECONCILE RAW DATA FROM THE TESTING INSTRUMENT WITH RESULTS GENERATED BY THE COVID INTERPRETIVE SOFTWARE WERE UNSUCCESSFUL. CONSEQUENTLY, 7 POSITIVE SAMPLES WERE REPORTED UTILIZING ANOTHER PLATFORM. ONLY 2 OF THE 7 CONFIRMED AS POSITIVE. THE 5 FALSE POSITIVES WERE REPORTED TO (B)(6) AND TO THE HEALTH DEPARTMENT. ON (B)(6) 2020 THE (B)(6) CLINICAL LABORATORY DETERMINED THAT ALL NEW POSITIVE RESULTS WOULD BE MANUALLY REVIEWED AND ANY QUESTIONABLE RESULTS WOULD BE REPEATED ON A SEPARATE PLATFORM. ON (B)(6) 2020, LABORATORY LEADERSHIP CONCLUDED THAT ALL POSITIVE RESULTS TESTED ON THIS INSTRUMENT PRIOR TO (B)(6) SHOULD ALSO BE REVIEWED. RESULTS WITH A DISCREPANCY BETWEEN THE RAW DATA AND THAT SOFTWARE INTERPRETATION WERE RETESTED ON A DIFFERENT TESTING PLATFORM. THIS RETESTING IDENTIFIED A TOTAL OF 29 FALSE POSITIVE RESULTS, WHICH IMPACTED 19 (B)(6) PATIENTS AND 10 EXTERNAL ACCOUNTS. AS OF TUESDAY (B)(6) 2020, ALL POSITIVES FROM THE THERMO FISHER ARE BEING CONFIRMED UTILIZING ANOTHER PLATFORM PRIOR TO RELEASE OF RESULTS. ALL FALSE POSITIVES WILL HAVE CORRECTED REPORTS ISSUED. ALL PATIENTS, PROVIDERS AND THE APPROPRIATE HEALTH DEPARTMENTS WILL BE NOTIFIED. THE INSTRUMENT MANUFACTURER HAS BEEN NOTIFIED OF OUR FINDINGS. THE (B)(6) CLINICAL LABORATORY HAS RIGOROUSLY FOLLOWED THE PROCEDURE AS PROVIDED BY THERMO FISHER FOR TESTING UTILIZING THIS FDA EUA PLATFORM.