RealTime 09N77-095Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00884999049109), received between Apr 27, 2020 and Mar 3, 2022 — classified as 57 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (42 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT ON THE REALTIME SARS-COV-2 ASSAY. THE PATIENT SAMPLE WAS TESTED TWICE ON THE SAME RUN. ONE RESULT WAS "NOT DETECTED" AND THE OTHER RESULT WAS POSITIVE. THE CUSTOMER REPORTED THE NEGATIVE RESULT OUT OF THE LAB AND DID NOT SEE ANY FURTHER NEED FOR REPEAT TESTING. THERE WAS NO REPORT OF IMPACT TO THE PATIENT. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN MACEDONIA USING THE REALTIME SARS-COV-2 ASSAY, LIST NUMBER 9N77-90, WHICH IS THE SAME/ SIMILAR TO THE REALTIME SARS-COV-2 ASSAY, LIST NUMBER 9N77-95, WHICH RECEIVED FDA EUA APPROVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664929 ↗
• MalfunctionFeb 14, 2022False Positive Result; False Positive Result

  CUSTOMER CALLED TO REPORT AT LEAST 6 FALSE POSITIVE RESULTS, LATER CLARIFIED AS 10, WHEN RUNNING THE REALTIME SARS-COV-2 ASSAY. CUSTOMER NOTIFIED ABBOTT THAT THE LAB STAFF IS REPEATING ALL REALTIME SARS-COV-2 PATIENT SAMPLES THAT GENERATE A POSITIVE RESULT WITH A CYCLE NUMBER (CN) OVER 28. ALL SARS-COV-2 PATIENT SAMPLES REPORTED AS POSITIVE BY THE ASSAY ARE REVIEWED BY LAB STAFF. ANY POSITIVE SAMPLE WITH CN AT 28 OR MORE ARE REPEATED ON THE CUSTOMER'S SECOND M2000 SYSTEM. THE SAME SAMPLE ALIQUOT IS USED TO PERFORM THE SECONDARY TEST. REPEATED RESULT IS NEGATIVE. CONFIRMATION TESTING IS DONE ON BDMAX AND CEPHEID PANELS (SAME ALIQUOT), AND THE RESULT IS NEGATIVE FOR ALL PREVIOUSLY POSITIVE SAMPLES WITH CN 28 AND OVER. REVIEW BY GLOBAL SERVICE AND SUPPORT INDICATES THAT LOG FILE ANALYSIS CONCLUDED THERE IS NO INDICATION OF ANY SYSTEM OR REAGENT PERFORMANCE ISSUES. NINE OF THE TEN DISCREPANT RESULTS ARE MOST LIKELY ATTRIBUTED TO THE VIRAL CONCENTRATIONS NEAR OR BELOW THE LIMIT OF DETECTION OF THE ASSAY. DISCUSSION WITH THE CUSTOMER OFFERED RESOLUTION FOR REPORTING LOW-GRADE POSITIVE SARS-COV-2 ASSAY RESULTS RATHER THAN HAVING THE SAMPLES RE-TESTED. IN THE FUTURE, THE CUSTOMER WILL INCL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529476 ↗
• MalfunctionFeb 14, 2022False Positive Result; False Positive Result

  CUSTOMER CALLED TO REPORT AT LEAST 6 FALSE POSITIVE RESULTS, LATER CLARIFIED AS 10, WHEN RUNNING THE REALTIME SARS-COV-2 ASSAY. CUSTOMER NOTIFIED ABBOTT THAT THE LAB STAFF IS REPEATING ALL REALTIME SARS-COV-2 PATIENT SAMPLES THAT GENERATE A POSITIVE RESULT WITH A CYCLE NUMBER (CN) OVER 28. ALL SARS-COV-2 PATIENT SAMPLES REPORTED AS POSITIVE BY THE ASSAY ARE REVIEWED BY LAB STAFF. ANY POSITIVE SAMPLE WITH CN AT 28 OR MORE ARE REPEATED ON THE CUSTOMER'S SECOND M2000 SYSTEM. THE SAME SAMPLE ALIQUOT IS USED TO PERFORM THE SECONDARY TEST. REPEATED RESULT IS NEGATIVE. CONFIRMATION TESTING IS DONE ON BDMAX AND CEPHEID PANELS (SAME ALIQUOT), AND THE RESULT IS NEGATIVE FOR ALL PREVIOUSLY POSITIVE SAMPLES WITH CN 28 AND OVER. REVIEW BY GLOBAL SERVICE AND SUPPORT INDICATES THAT LOG FILE ANALYSIS CONCLUDED THERE IS NO INDICATION OF ANY SYSTEM OR REAGENT PERFORMANCE ISSUES. NINE OF THE TEN DISCREPANT RESULTS ARE MOST LIKELY ATTRIBUTED TO THE VIRAL CONCENTRATIONS NEAR OR BELOW THE LIMIT OF DETECTION OF THE ASSAY. DISCUSSION WITH THE CUSTOMER OFFERED RESOLUTION FOR REPORTING LOW-GRADE POSITIVE SARS-COV-2 ASSAY RESULTS RATHER THAN HAVING THE SAMPLES RE-TESTED. IN THE FUTURE, THE CUSTOMER WILL INCL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529459 ↗
• MalfunctionJan 31, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS ON THE REALTIME SARS-COV-2 ASSAY. CUSTOMER STATES THERE WERE 10 PATIENT SPECIMENS THAT WERE HIGH CN POSITIVES. THEY WERE REPEATED ON THE ALINITY M INSTRUMENT AS NEGATIVE. THE MOLECULAR APPLICATION SPECIALIST (MAS) REVIEWED THE LOGS. THERE WAS NO INDICATION OF A CARRYOVER EVENT. THE CUSTOMER CONFIRMED THERE WAS NO IMPACT TO PATIENT MANAGEMENT AS THE RESULTS WERE NOT REPORTED OUT AS POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13391987 ↗
• MalfunctionOct 1, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 14 FALSE POSITIVE RESULTS ON A REALTIME SARS-COV-2 ASSAY. THE CUSTOMER RETESTED 15 SAMPLES WHICH HAD TESTED POSITIVE ON THE REALTIME SARS-COV-2 ASSAY AFTER THE PATIENT FACILITY QUESTIONED THE RESULTS. THE RETESTS WERE PERFORMED ON THE HOLOGIC APTIMA ASSAY AND 14 OF THE SAMPLES YIELDED NEGATIVE RESULTS. THE CUSTOMER COULD NOT PROVIDE ANY INFORMATION ABOUT IF THERE WAS ANY IMPACT TO PATIENT MANAGEMENT. THE CUSTOMER SITE PROVIDED ADDITIONAL INFORMATION TO CLARIFY THEIR OBSERVATIONS. AN INVESTIGATION WAS INITIATED WITH 67 M2000 RUNS EXAMINED, FOR A TOTAL OF 5750 SAMPLES. OF THOSE 5750 SAMPLES, 44 SAMPLES HAD CYCLE NUMBERS (CN) OF 25.0 - 31.5, WHICH YIELDED 0.77% OF SAMPLES WITH HIGH CN. CUSTOMER DID NOT REPEAT ANY OF THOSE SAMPLES, HOWEVER AFTER THE INVESTIGATION, IT WAS DECIDED TO REPEAT ANY SAMPLES >25CN ON ANOTHER PLATFORM TO CONFIRM. A LONG TERM FACILITY QUESTIONED POSITIVE COVID RESULTS FROM VACCINATED PATIENTS: ON (B)(6) 2021, THE LONG TERM CARE FACILITY QUESTIONED A POSITIVE COVID RESULT FROM A VACCINATED PATIENT. THE SPECIMEN WAS RECEIVED (B)(6) 2021 AND WAS RUN ON THE ABBOTT M2000 INSTRUMENT WITH A RESULT OF 31.13 CN. THE CUTOFF VALUE FOR THIS ASSAY IS 31

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565843 ↗
• MalfunctionJul 16, 2021False Positive Result; False Positive Result

  THE CUSTOMER SITE PROVIDED ADDITIONAL INFORMATION TO CLARIFY THEIR OBSERATIONS. AN INVESTIGATION WAS INITIATED WITH 67 M2000 RUNS EXAMINED, FOR A TOTAL OF 5750 SAMPLES. OF THOSE 5750 SAMPLES, 44 SAMPLES HAD CYCLE NUMBERS (CN) OF 25.0 - 31.5, WHICH YIELDED 0.77% OF SAMPLES WITH HIGH CN. CUSTOMER DID NOT REPEAT ANY OF THOSE SAMPLES, HOWEVER AFTER THE INVESTIGATION, IT WAS DECIDED TO REPEAT ANY SAMPLES >25CN ON ANOTHER PLATFORM TO CONFIRM. A LONG TERM FACILITY QUESTIONED POSITIVE COVID RESULTS FROM VACCINATED PATIENTS: ON (B)(6) 2021, THE LONG TERM CARE FACILITY QUESTIONED A POSITIVE COVID RESULT FROM A VACCINATED PATIENT. THE SPECIMEN WAS RECEIVED (B)(6) 2021 AND WAS RUN ON THE ABBOTT M2000 INSTRUMENT WITH A RESULT OF 31.13 CN. THE CUTOFF VALUE FOR THIS ASSAY IS 31.5 CN, SO ALTHOUGH THIS SAMPLE WAS RESULTED AS POSITIVE, IT WAS VERY CLOSE TO THE CUTOFF. THIS SAMPLE WAS THE ONLY POSITIVE ON THE RUN, AND THE QUALITY CONTROL (QC) WAS ACCEPTABLE. AFTER THE FACILITY SAW THIS SAMPLE WAS POSITIVE, THEY SUBMITTED A SECOND SAMPLE ON (B)(6) 20201. THE SECOND SAMPLE WAS RUN ON THE PANTHER ON (B)(6) 2021, AND IT WAS NEGATIVE. BOTH SAMPLES WERE SUBSEQUENTLY RUN ON THE TAQPATH ASSAY ON 3/19/2021, A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12185643 ↗
• MalfunctionJul 15, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED DISCREPANT RESULT OF FALSE POSITIVE WHEN RUNNING THE REALTIME SARS-COV-2 ASSAY. PER THE CUSTOMER, THE NASOPHARYNGEAL SAMPLE WAS COLLECTED AT A REMOTE LOCATION AND TRANSPORTED REFRIGERATED. THE SAMPLE WAS STORED REFRIGERATED IN THE LAB. CUSTOMER REQUESTED THE MOLECULAR APPLICATION SPECIALIST (MAS) TO PERFORM A LOG REVIEW. THE MAS REVIEWED AMPLIFICATION CURVES FOR THE RUNS IN QUESTION AND DETERMINED THAT FIRST SAMPLE ON (B)(6) GENERATED A POSITIVE RESULT. IT WAS CONFIRMED THE INITIAL POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN AND WAS RETESTED AT THE PHYSICIAN'S REQUEST. THE SAME SAMPLE WAS RE-RUN ON (B)(6) AND THE RESULT WAS NEGATIVE. PHYSICIAN WAS NOTIFIED OF THIS CORRECTED RESULT. THERE HAS BEEN NO REPORT OF IMPACT TO PATIENT MANAGEMENT DUE TO THIS OBSERVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12173992 ↗
• MalfunctionJun 24, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED DISCREPANT RESULT OF FALSE POSITIVE WHEN RUNNING THE REALTIME SARS-COV-2 ASSAY. CUSTOMER REQUESTED THE MOLECULAR APPLICATION SPECIALIST TO PERFORM A LOG REVIEW FOR SAMPLE (B)(6) COLLECTED IN A UNIVERSAL MULTI-COLLECT TUBE, WHICH WAS RUN THREE TIMES. THE CUSTOMER STATED THEY WERE CONCERNED BECAUSE THE THIRD SAMPLING WOULD HAVE MADE THE MINIMUM VOLUME LOWER THAN THAT SPECIFIED IN THE REALTIME SARS COV-2 PACKAGE INSERT. THE CUSTOMER LATER REVEAL THE FIRST SAMPLING YIELDED A NEGATIVE RESULT. THE SAME WAS RE-RUN AS A KNOWN NEGATIVE, BUT IT RESULTED POSITIVE IN SUBSEQUENT RUNS. PER THE CUSTOMER, THE NASOPHARYNGEAL SAMPLE WAS COLLECTED AT A REMOTE LOCATION AND TRANSPORTED REFRIGERATED. THE SAMPLE WAS STORED REFRIGERATED IN THE LAB AND ALL SAMPLINGS OF IT WERE PERFORMED WITHIN 72 HOURS OF COLLECTION. THE MOLECULAR APPLICATION SPECIALIST (MAS) ADVISED CUSTOMER TO PERFORM AN ENVIORNMENTAL CONTAMINATION CHECK AND MAKE SURE ENVIRONMENTAL MONITORING IS UP-TO-DATE. MAS REVIEWED AMPLIFICATION CURVES FOR THE RUNS IN QUESTION AND DETERMINED THAT THE CURVES APPEAR VALID, WITH NO NOISE. MAS DID NOTICE THE SAMPLE IN QUESTION WAS ADJACENT TO A HIGH POSITIVE SAMPLE ON THE PLATE. MA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12061486 ↗
• MalfunctionJun 16, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 17 FALSE POSITIVE RESULTS ON 2 RUNS OF THE REALTIME SARS-COV-2 ASSAY. THE CUSTOMER INITIALLY QUESTIONED THE RESULTS BECAUSE SOME OF THE PATIENTS ON THE RUN WERE PRE SURGERY SCREENINGS AND WERE NOT EXPECTED TO BE POSITIVE. SOME OF THE SAMPLES ALSO TESTED POSITIVE ON CEPHID, WHICH LED THE CUSTOMER TO SUSPECT CONTAMINATION OF THE ORIGINAL SAMPLES DUE TO HANDLING. FOR THOSE SAMPLES THAT WERE POSITIVE ON BOTH ASSAYS, THE CUSTOMER COLLECTED NEW SAMPLES AND TESTED THEM ON ANOTHER PLATFORM GENERATING A NEGATIVE RESULT. SOME PATIENT SURGERIES HAD TO BE RESCHEDULED OR CANCELLED, SO THERE WAS AN IMPACT TO PATIENT MANAGEMENT WITH NO REPORT OF DEATH OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009991 ↗
• MalfunctionMay 11, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 21 FALSE POSITIVE RESULTS ON A REALTIME SARS-COV-2 ASSAY. THE CUSTOMER SUSPECTED CONTAMINATION ON THEIR M2000RT INSTRUMENT, SO THEY RETESTED ALL 21 SAMPLES ON AN ALINITY M INSTRUMENT AND RECEIVED NEGATIVE RESULTS. THE POSITIVE RESULTS WERE NOT REPORTED OUTSIDE THE LAB, SO THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810157 ↗
• MalfunctionMar 23, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED EIGHT FALSE POSITIVE RESULTS ON A REALTIME SARS-COV-2 ASSAY. REVIEW OF THE AMPLIFICATION CURVES INDICATE THE SAMPLES HAVE A POSITIVE CYCLE NUMBER VALUE, BUT SHOW NO AMPLIFICATION. THE CUSTOMER RETESTED THE SAMPLES ON AN ALINITY M INSTRUMENT AND GOT NEGATIVE RESULTS. THE FALSE POSITIVE RESULTS WERE NOT REPORTED OUT OF THE LAB, SO THERE WAS NO IMPACT ON PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11558489 ↗
• MalfunctionMar 23, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULTS ON A REALTIME SARS-COV-2 ASSAY. A PATIENT TESTED POSITIVE FOR SARS-COV-2 ON THE REALTIME SARS-COV-2 ASSAY ON (B)(6). A PHYSICIAN QUESTIONED THE RESULTS, SO THEY WERE RETESTED THE FOLLOWING DAY WITH A NEW SAMPLE, (B)(6), WITH NEGATIVE RESULTS. THE PATIENT HAD ALSO TESTED NEGATIVE ON (B)(6) WITH A THIRD DIFFERENT SAMPLE. ALL ASSAY PARAMETERS, SUCH AS ASSAY CONTROLS, INTERNAL CONTROL, REFERENCE DYE PERFORMED AS PER SPECIFICATIONS. THE CUSTOMER WAS NOT ABLE TO BE REACHED AFTER BEING CONTACTED THREE SEPARATE TIMES FOR ADDITIONAL INFORMATION. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11554132 ↗
• MalfunctionJan 27, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED ONE PATIENT SAMPLE FROM EARLY JANUARY 5TH GENERATED A POSITIVE RESULT FOR REALTIME SARS-COV-2 ASSAY, WHICH WAS DISPUTED BY THE PHYSICIAN. SAMPLE WAS COLLECTED, TRANSPORTED TO THE LAB, AND TESTED ON THE SAME DAY. THIS PATIENT HAS BEEN DOING REGULAR COVID TESTING AND HAS BEEN NEGATIVE ON THE PREVIOUS TWO TESTS. THE RESULT WAS OBTAINED EARLY IN THE MORNING AND FORWARDED TO PHYSICIAN. THE POSITIVE RESULT WAS DISPUTED BY PATIENT'S PHYSICIAN AND REPEATED ON AN ALTERNATIVE PLATFORM, AND THE RESULT WAS NEGATIVE. THE SAME SAMPLE TUBE WAS USED FOR THE RE-TEST ON THE ALTERNATIVE PLATFORM. THE CUSTOMER WAS INSTRUCTED TO MAKE SURE NO CONTAMINATION IS PRESENT IN PROCESSING, AS A POSSIBLE CONTAMINATION COULD BE THE CAUSE OF THE POSITIVE RESULT. THE LAB DIRECTOR IS EXTREMELY FAMILIAR WITH DECONTAMINATION METHODS. FOLLOWING THE CALL AND DISCUSSION WITH CUSTOMER, INSTRUMENT AND THE LAB HAVE BEEN THOROUGHLY CLEANED AND ENVIRONMENTAL CHECKS WERE PERFORMED TO CONFIRM ABSENSE OF ANY DETECTABLE CONTAMINATION. FINAL IMPACT ON PATIENT MANAGEMENT IS NOT KNOWN, AS PER CUSTOMER; HOWEVER THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT AS THE RESULT WAS QUESTIONED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11238918 ↗
• MalfunctionDec 11, 2020False Positive Result; False Positive Result

  CUSTOMER STATED THAT THEY HAVE EXPERIENCED DISCREPANT RESULTS WITH THE REALTIME SARS-COV-2 ASSAY. CUSTOMER STATED THAT THEY HAVE EXPERIENCED 1-3 DISCREPANT RESULTS PER (B)(4) SINCE (B)(4). CUSTOMER CONFIRMED THROUGH ENVIRONMENTAL TESTING THAT NO ENVIRONMENTAL CONTAMINATION EXISTS. CUSTOMER NOTED AN ODD LATE RISING TARGET CURVE FOR THESE SPECIMENS. CUSTOMER REPEATED THESE SAMPLES ON CEPHEID, AND THEY GENERATE A NEGATIVE RESULT. ALLEGED FALSE POSITIVE RESULTS ARE NOT RELEASED, RATHER SUCH QUESTIONABLE RESULTS ARE RE-TESTED ON CEPHEID. IMPACT ON PATIENT MANAGEMENT FOR SAMPLES IN QUESTION IS NOT KNOWN; HOWEVER AS QUESTIONED REALTIME RESULTS WERE NOT RELEASED OUTSIDE THE LABORATORY THESE QUESTIONED RESULTS WERE NOT MADE AVAILABLE TO HAVE IMPACT ON PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10992643 ↗
• MalfunctionDec 11, 2020False Positive Result; False Positive Result

  WHEN RUNNING THE REALTIME SARS-COV-2 ASSAY, CUSTOMER REPORTED 4 DISCREPANT POSITIVE RESULT CASES RECORDED IN THE PERIOD OF SEPT. 15 TO NOV. 11. THE 4 RECORDED DISCREPANT RESULT CASES WERE ALL FROM INTERNAL STAFF BEING TESTED AND RESULTS WERE QUESTIONED BY THE IN-HOUSE PHYSICIAN. THERE WAS NO KNOWN IMPACT ON PATIENT MANAGEMENT, ACCORDING TO THE CUSTOMER. SAMPLE COLLECTION AND TESTING WAS DONE WITHIN THE LAB. ALL FOUR CASES WERE LOW GRADE POSITIVE ON THE FIRST RUN. THE SECOND RUN WAS DONE SOMETIME LATER WITH A DIFFERENT COLLECTION TUBE. THE SAMPLES IN QUESTION WERE EACH REPEATED ONE TO THREE TIMES. ALL REPEATED TESTS WERE NEGATIVE. THE MOLECULAR APPLICATION SPECIALIST (MAS) REVIEWED AVAILABLE DATA FOR RUNS CONTAINING RE-TEST SAMPLES. THESE RUNS APPEAR AS EXPECTED, ALL ASSAY PARAMETERS, INCLUDING IC RESPONSE, TARGET RECOVERY FOR THE POSITIVE SAMPLES AND CONTROLS, BACKGROUND DYE IS FLAT WITH NO WAVINESS. THE MAS REVIEWED WITH THE CUSTOMER PROPER SAMPLE HANDLING PRIOR TO PROCESSING: UNCAPPED SAMPLE TUBES SHOULD BE PLACED INTO SAMPLE RACKS USING GREAT CAUTION TO PREVENT CHANCES OF CROSS-CONTAMINATION. SINCE DATA IS NOT AVAILABLE TO LOOK AT THE RUNS IN QUESTION, POSSIBLE CAUSE OF DISCREPA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10992410 ↗
• MalfunctionDec 10, 2020False Positive Result; False Positive Result

  CUSTOMER CALLED TO REPORT THAT 24 SAMPLES IN ONE RUN WERE CALLED AS LATE POSITIVE RESULTS ON THE REALTIME SARS-COV-2 ASSAY, BUT THEY WERE CALLED NEGATIVE ON RE-TEST. CUSTOMER INDICATED THAT SAMPLES ARE IN 2 ML VIRAL TRANSPORT MEDIA. CUSTOMER INDICATES THE RUN IN QUESTION WAS PERFORMED ON (B)(6). THE MOLECULAR APPLICATION SPECIALIST (MAS) REVIEWED RUN DATA TO FIND MANY OF THE POSITIVE IN ROW H. MAS ATTEMPTED TO ASK CUSTOMER ABOUT AMPLIFICATION REAGENT THAWING; HOWEVER, THERE WAS NO ANSWER. MAS ATTEMPTED TO FOLLOW UP WITH THE CUSTOMER IN REGARDS TO TROUBLESHOOTING AS WELL AS TO UNDERSTAND WHAT RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND IF THERE WAS ANY IMPACT TO PATIENT MANAGEMENT. RESPONSES WERE NOT RECEIVED; BELOW IS A CHRONOLOGY OF ATTEMPTS: 18 NOVEMBER MAS CALLED LAB. CUSTOMER NOT AVAILABLE; MAS LEFT A MESSAGE. 19 NOVEMBER MAS CALLED TO ASK CUSTOMER FOLLOW-UP QUESTIONS. CUSTOMER INDICATED THAT HIS SUPERVISOR WOULD HAVE TO ANSWER THEM. SUPERVISOR WAS OUT OF THE OFFICE. MAS AGREED TO SEND THE LIST OF QUESTIONS TO THE CUSTOMER. CUSTOMER AGREED TO PRESENT THE QUESTIONS TO HIS SUPERVISOR TO ADDRESS. 23 NOVEMBER MAS CALLED TO FOLLOW UP WITH CUSTOMER. THERE WAS NO ANSWER. 10 DECEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10988692 ↗
• MalfunctionOct 27, 2020False Positive Result; False Positive Result

  CUSTOMER STATED THAT THEIR RUN FROM LAST WEEK HAD HALF THE SAMPLES GENERATE POSITIVE RESULTS, WHICH LED THE CUSTOMER TO SUSPECT CONTAMINATION AS THE CAUSE OF THE ISSUE. CUSTOMER WAS RUNNING PATIENT SAMPLES. THESE SUSPECT RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND WERE REPEATED, THEREFORE, SUSPECT RESULTS DID NOT IMPACT PATIENT MANAGEMENT. OF 47 REPEATED SAMPLES, 12 COME BACK AS TRUE POSITIVE. THE CUSTOMER CLEANED THE INSTRUMENT, SURFACES, AND RE-TIGHTENED ALL FITTINGS. CUSTOMER ALSO PERFORMED CONTAMINATION CHECK AND CLEANED WELLS AND RAN BACKGROUND PLATE, FOLLOWED BY AN ENVIRONMENTAL RUN IN WHICH ALL ENVIRONMENTAL SAMPLES CAME UP NEGATIVE. CUSTOMER STATED THAT THE INSTRUMENT AND ASSAY HAVE BEEN PERFORMING AS EXPECTED SINCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10741866 ↗
• MalfunctionOct 27, 2020False Positive Result; False Positive Result

  CUSTOMER REPORTED FALSE POSITIVE RESULTS WERE GENERATED WHEN RUNNING THE REALTIME SARS-COV-2 ASSAY. THE FALSE POSITIVE RESULTS WERE CONFIRMED ON ANOTHER PLATFORM TO BE NEGATIVE. THE FALSE POSITIVE RESULTS WERE NOT REPORTED TO THE PHYSICIAN, AND DID NOT ADVERSELY AFFECT PATIENT MANAGEMENT. MOLECULAR APPLICATION SPECIALIST (MAS) REVIEWED DATA FILES, HAD THE CUSTOMER PERFORM A CONTAMINATION CHECK, AND AN OPTICAL CALIBRATION. MAS ASKED IF THE CUSTOMER HAD BUMPED INTO THE TABLE OR M2000RT INSTRUMENT. CUSTOMER REPORTED, "[THEY] DID NOT THINK SO." CUSTOMER REPORTED TWO SUCCESSFUL SARS COV-2 RUNS AFTER OPTICAL CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10741454 ↗
• MalfunctionOct 27, 2020False Positive Result; False Positive Result

  CUSTOMER REPORTED THAT WHEN RUNNING A REALTIME SARS COV-2 PATIENT SPECIMEN THE INITIAL TEST GENERATED A POSITIVE RESULT, BUT ON REPEAT A NEGATIVE RESULT WAS GENERATED. CUSTOMER WANTED TO KNOW THE CUTOFF CYCLE NUMBER (CN) FOR THE ASSAY. MOLECULAR APPLICATION SPECIALIST (MAS) EXPLAINED THAT BOTH THE MAXIMUM RATIO AND THE CN ARE USED IN INTERPRETING RESULTS FOR THIS ASSAY. CUSTOMER SAID THE SAMPLE WAS RE-RUN BECAUSE THE CN WAS HIGH (31.30). CUSTOMER CLARIFIED THAT THE SAMPLE WAS REREUN BECAUSE THE RESULTS SHOWED AN INTERNAL CONTROL FLAG. HE STATED HE THINKS THE PATIENT WAS BORDERLINE, AND THAT IS WHY THE RESULTS WERE DIFFERENT FROM EACH OTHER. THE LAB ASKED FOR A RE-COLLECT, BUT CUSTOMER DOES NOT BELIEVE A RE-COLLECT WAS DONE. NO RESULTS WERE REPORTED OUTSIDE THE LAB; THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10741302 ↗
• MalfunctionOct 27, 2020False Positive Result; False Positive Result

  CUSTOMER REPORTED, FOR A PATIENT NO LONGER EXHIBITING SYMPTOMS, A CLINICIAN QUESTIONED A POSITIVE RESULT GENERATED ON THE REALTIME SARS COV-2 ASSAY. CUSTOMER REPORTED THE CLINICIAN QUESTIONED THE POSITIVE RESULT AND THE SAMPLE WAS RETESTED ON ANOTHER PLATFORM USING A LABORATORY DEVELOPED TEST (LDT) ASSAY. THE LDT ASSAY RESULT WAS NEGATIVE. SAMPLE WAS RECOLLECTED FROM THE PATIENT AND TESTED ON THE REALTIME SARS-COV-2 ASSAY. RECOLLECTED SAMPLE WAS NEGATIVE. ORIGINAL RESULT WAS AMENDED AND REPORTED AS A FALSE POSITIVE. PATIENT MANAGEMENT WAS NOT IMPACTED AND PATIENT WAS NOT ADVERSELY AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10741120 ↗
• MalfunctionOct 27, 2020False Positive Result; False Positive Result

  DURING ROUTINE TESTING OF LABORATORY PERSONNEL, ONE OF THE LAB TECHNICIAN SAMPLES GENERATED A POSITIVE RESULT ON THE REALTIME SARS-COV-2 ASSAY. SAMPLE WAS RE-TESTED WITH A DIFFERENT PLATFORM AND WITH THE REALTIME ASSAY AND GENERATED A NEGATIVE RESULT. CUSTOMER IS NOT CERTAIN WHETHER THE SAME ALIQUOT WAS TESTED IN BOTH RUNS. THE CUSTOMER WAS CONCERNED THAT THEY HAD TO REPEAT SPECIMENS ON A DIFFERENT PLATFORM. THERE WAS ALSO CONCERN THAT THE INTEGRITY OF SOME OF THE SPECIMENS DETERIORATED AND GAVE INCONCLUSIVE RESULTS AND THAT THERE WAS DAYS OF DELAY FOR SOME SPECIMENS. THE MAS FOLLOWED UP WITH THE CUSTOMER TO CLARIFY WHETHER THERE WAS MORE THAN ONE SPECIMEN REPEATED ON A DIFFERENT PLATFORM ALONG WITH THE PATIENT SAMPLE (THE LAB TECHNICIAN) IN QUESTION. THERE WERE OTHER SAMPLES REPEATED ALONG WITH THE SAMPLE IN QUESTION; THERE WERE NO OTHER DISCREPANT RESULTS DETECTED. THE CUSTOMER CLARIFIED THAT THE LAB TECHNICIAN'S HEALTH MANAGEMENT WAS NOT AFFECTED BY TEST RESULTS. CUSTOMER EXPRESSED CONCERN ABOUT DELAYS IN RESULTS REPORTING AS A SEPARATE ISSUE, AFFECTING THE LAB AND PATIENT MANAGEMENT. THERE WAS A DELAY IN RESULT REPORTING DUE TO AN EXTRA TIME FOR REPEAT TESTING. THERE IS NO KNOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10740865 ↗
• MalfunctionOct 27, 2020False Positive Result; False Positive Result

  CUSTOMER IS CONCERNED THAT WHEN RUNNING THE REALTIME SARS-COV-2 ASSAY SOME SAMPLES GENERATE A POSITIVE RESULT BUT DO NOT REPEAT AS POSITIVE WHEN RUN ON THE REALTIME SARS-COV-2 ASSAY, OR WHEN RE-COLLECTED AND RE-RUN, OR WHEN TESTED ON OTHER PLATFORMS SUCH AS CDC/STATE LAB, CEPHEID, OR ABBOTT ID NOW. CUSTOMER STATES THAT SOME AMPLIFICATION CURVES LOOK NOISY. CUSTOMER LATER COMMUNICATED THAT THEY HAVE REVIEWED THE RESULTS INTERNALLY AND NO LONGER HAVE A NEED TO DISCUSS. THE CUSTOMER WILL CONTINUE TO USE THE SYSTEM. HE SAID THAT DURING THEIR INTERNAL DATA REVIEW, THEY COMPARED THE VARIOUS PLATFORMS WITH REGARD TO SENSITIVITY, SPECIFICITY, AND OTHER ASSAY VARIABLES. THEY DECIDED THERE WERE TOO MANY VARIABLES IN PLAY TO DRAW CONCLUSIONS ABOUT COMPARING RESULTS FROM DIFFERENT PLATFORMS. THE CUSTOMER THEN DECIDED TO CLOSELY MONITOR THE QUALITY PARAMETERS OF THE REALTIME PLATFORM, SUCH AS INTERNAL CONTROL, EXTERNAL CONTROLS, AND AMPLIFICATION CURVE PROFILES. IF ALL OF THOSE PARAMETERS ARE IN ORDER, THEY WILL CONCLUDE THE RESULT IS VALID. THERE HAS BEEN NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10740502 ↗
• MalfunctionOct 27, 2020False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THAT BETWEEN (B)(6) 2020, THERE WERE 94 REALTIME SARS-COV-2 SAMPLES IDENTIFIED AS POSSIBLE FALSE POSITIVE. 94 SARS-COV2 PATIENT RESULTS WERE REPORTED AS POSITIVE. SOME OF THE POSITIVE RESULTS WERE QUESTIONED BY CLINICIANS. ALL POSITIVE SAMPLES FROM RUNS BETWEEN (B)(6) 2020 WERE RE-TESTED ON A DIFFERENT PLATFORM. CUSTOMER USED THE PRIMARY TUBES TO RUN CONFIRMATORY TESTING. 10 OUT OF 94 PREVIOUSLY REPORTED SARS-COV2 POSITIVE RESULTS WERE CONFIRMED AS POSITIVE. ON(B)(6) 2020, THE CUSTOMER ALSO EXPERIENCED A FAILED REALTIME SARS-COV-2 RUN DUE TO ERROR CODE 4423, NEGATIVE CONTROL IS REACTIVE (TICKET (B)(4)). CUSTOMER WAS ADVISED AT THAT TIME TO TEST ENVIRONMENTAL SAMPLES. ENVIRONMENTAL RUN WAS SET UP ON (B)(6) 2020: 8 OUT OF 22 TESTED ENVIRONMENTAL SAMPLES WERE POSITIVE. CUSTOMER HAS BEEN ADVISED TO PERFORM LABORATORY DECONTAMINATION PROCEDURES. THE MOST LIKELY CAUSE OF THE HIGH NUMBER FALSE POSITIVE SARS-COV-2 PATIENT RESULTS IS DUE TO ENVIRONMENTAL CONTAMINATION IN THE LABORATORY. AMBASSADOR ASSISTED WITH DECONTAMINATION PROCEDURES, AND REPORTED THAT NO MORE CONTAMINATION WAS DETECTED. DURING THIS CONTAMINATION ISSUE PERIOD, WHEN THE NEGATIVE CONTROL WOULD PASS T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10740489 ↗
• MalfunctionOct 27, 2020False Positive Result; False Positive Result

  THE CUSTOMER CALLED TO REPORT A PATIENT SAMPLE THAT GENERATED A POSITIVE RESULT ON THE REALTIME SARS-COV-2 ASSAY BUT GENERATED A NEGATIVE RESULT WHEN RUN ON THE CEPHEID AND DIASORIN ASSAYS. THE PATIENT RESULT WAS REPORTED AS POSITIVE BASED ON THE REALTIME SARS-COV-2 ASSAY RESULT. THE CUSTOMER CLARIFIED THAT THE PATIENT RESULT WAS QUESTIONED BY THE PHYSICIAN SINCE PATIENT WAS ASYMPTOMATIC. PATIENT SAMPLE TEST WAS THEN REPEATED ON PARALLEL PLATFORMS. MOLECULAR APPLICATION SPECIALIST REVIEWED LOGS. RUN APPEARS AS EXPECTED, ASSAY CONTROLS, INTERNAL AND EXTERNAL PERFORMED AS EXPECTED. FURTHER DECISION ABOUT PATIENT MEDICAL TREATMENT IS NOT KNOWN. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10740105 ↗
• MalfunctionOct 23, 2020False Positive Result; False Positive Result

  CUSTOMER CALLED TO REPORT AT LEAST 6 FALSE POSITIVE RESULTS, LATER CLARIFIED AS 10, WHEN RUNNING THE REALTIME SARS-COV-2 ASSAY. CUSTOMER NOTIFIED ABBOTT THAT THE LAB STAFF IS REPEATING ALL REALTIME SARS-COV-2 PATIENT SAMPLES THAT GENERATE A POSITIVE RESULT WITH A CYCLE NUMBER (CN) OVER 28. ALL SARS-COV-2 PATIENT SAMPLES REPORTED AS POSITIVE BY THE ASSAY ARE REVIEWED BY LAB STAFF. ANY POSITIVE SAMPLE WITH CN AT 28 OR MORE ARE REPEATED ON THE CUSTOMER'S SECOND M2000 SYSTEM. THE SAME SAMPLE ALIQUOT IS USED TO PERFORM THE SECONDARY TEST. REPEATED RESULT IS NEGATIVE. CONFIRMATION TESTING IS DONE ON BDMAX AND CEPHEID PANELS (SAME ALIQUOT), AND THE RESULT IS NEGATIVE FOR ALL PREVIOUSLY POSITIVE SAMPLES WITH CN 28 AND OVER. REVIEW BY GLOBAL SERVICE AND SUPPORT INDICATES THAT LOG FILE ANALYSIS CONCLUDED THERE IS NO INDICATION OF ANY SYSTEM OR REAGENT PERFORMANCE ISSUES. NINE OF THE TEN DISCREPANT RESULTS ARE MOST LIKELY ATTRIBUTED TO THE VIRAL CONCENTRATIONS NEAR, OR BELOW THE LIMIT OF DETECTION OF THE ASSAY. DISCUSSION WITH THE CUSTOMER OFFERED RESOLUTION FOR REPORTING LOW-GRADE POSITIVE SARS-COV-2 ASSAY RESULTS RATHER THAN HAVING THE SAMPLES RE-TESTED. IN THE FUTURE, THE CUSTOMER WILL INC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10731539 ↗