BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST

    MDR report key: 1846623 · Received September 28, 2010

    Report

    Report Number
    2243471-2010-00022
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    January 13, 2010
    Report Date
    February 26, 2010
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZF
    PMA / PMN Number
    BP050069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP REPORT 1. ADDITIONAL INFORMATION / DEVICE EVALUATION. DEVICE EVALUATED BY MANUFACTURER - YES. (B)(4) - HYDRAULIC SYSTEM, (B)(4) - CANNOT COMPLETE INVESTIGATION, INCOMPLETE DEVICE RETURNED, IT IS LIKELY THAT THE DISCREPANT RESULTS WERE CAUSED BY A CLOGGED REAGENT TIP. THE COBAS AMPLIPREP INSTRUMENT REAGENT TIP (R-TIP) ASPIRATES AND DISPENSES REAGENTS USED IN AUTOMATED SAMPLE PREPARATION. A DETAILED INVESTIGATION COULD NOT BE PERFORMED FOR THIS SPECIFIC COMPLAINT, AS THE CONCERNED R-TIP1 WAS DISCARDED BY THE CUSTOMER AND WAS NOT AVAILABLE FOR FURTHER TESTING. HOWEVER, IT IS LIKELY THAT THE DISCREPANT RESULTS WERE CAUSED BY A CLOGGED R-TIP AS THE ISSUE WAS RESOLVED AFTER REPLACING THE R-TIP1. THROUGH INTERNAL INVESTIGATIVE TESTING AND SIMULATED CLOGGING EVENTS, IT HAS BEEN IDENTIFIED THAT IN VERY RARE INSTANCES, A COBAS AMPLIPREP INSTRUMENT REAGENT TIP (R-TIP) MAY BECOME CLOGGED. A CLOGGED R-TIP HAS BEEN CHARACTERIZED BY A DELAYED QS CT VALUE, WHICH, IN TURN, HAS LEAD TO OVER-QUANTITATION AND QS INVALID RESULTS/INVALID TEST RUNS. (B)(4) FOR BLOOD SCREENING ASSAYS, THE ONLY POTENTIAL FAILURE IS AN INVALID TEST RUN OR AN INVALID TEST RESULT. THIS IS A USER INCONVENIENCE THAT IS NOT LIKELY TO CAUSE ANY SERIOUS ADVERSE HEALTH CONSEQUENCES OR MEDICALLY REVERSIBLE / TRANSIENT ADVERSE HEALTH CONSEQUENCES. FOR VIROLOGY ASSAYS, THE POTENTIAL FAILURES ARE AN INVALID TEST RUN, INVALID TEST RESULT OR OVER-QUANTITATION. AN INVALID TEST RUN OR INVALID TEST RESULT IS A USER INCONVENIENCE THAT IS NOT LIKELY TO CAUSE ANY SERIOUS ADVERSE HEALTH CONSEQUENCES. OVER-QUANTITATION MAY LEAD TO AN ERRONEOUS CHANGE IN DRUG THERAPY POTENTIALLY ASSOCIATED WITH MORE SEVER SIDE EFFECTS. HOWEVER, THE OCCURRENCE RATE OF THESE SIDE EFFECTS IS LIKELY TO BE LOW. BASED ON THE MEDICAL ASSESSMENT OF THIS ISSUE, IT WAS DETERMINED THAT THE PROBABILITY OF MEDICALLY REVERSIBLE OR TRANSIENT ADVERSE HEALTH CONSEQUENCES IS REMOTE AND THIS ISSUE IS NOT LIKELY TO CAUSE ANY SERIOUS ADVERSE HEALTH CONSEQUENCES. BASED ON THE FREQUENCY OF OCCURRENCE AND MEDICAL ASSESSMENT, IT WAS DETERMINED THAT THIS ISSUE WOULD NOT LIKELY LEAD TO DEATH OR SERIOUS DETERIORATION IN THE HEALTH OF A PATIENT. FURTHERMORE, AS WITH ANY DIAGNOSTIC TEST, TEST RESULTS SHOULD BE USED IN CONJUNCTION WITH CLINICAL PRESENTATION AND OTHER LABORATORY MARKERS FOR DISEASE PROGRESSION. FINALLY, THERE HAVE BEEN NO REPORTS OF SERIOUS INJURY OR DEATH ASSOCIATED WITH AN ALLEGATION OF A CLOGGED R-TIP. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THIS ISSUE IS STILL OPEN, AND THEREFORE, A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME. THE INVESTIGATION CONCLUSIONS WILL BE COMMUNICATED THROUGH A FOLLOW-UP MEDICAL DEVICE REPORT. ALTHOUGH THE INVESTIGATION INTO THIS ISSUE HAS NOT BEEN FINALIZED, IT IS BELIEVED THAT THIS ISSUE WAS THE RESULT OF A CLOGGED COBAS AMPLIPREP INSTRUMENT REAGENT TIP. THE REAGENT TIPS (R-TIPS) ARE USED ON THE COBAS AMPLIPREP INSTRUMENT TO ASPIRATE AND DISPENSE REAGENTS. WE RECOGNIZE THAT THIS MEDICAL DEVICE REPORT IS BEING FILED BEYOND THE 30-DAY REPORTING TIMEFRAME AS OUTLINED WITHIN 21 CFR 803.50. DURING A REVIEW OF OUR MDR PROCESS, WE DETERMINED THAT NOT ALL EVENTS THAT OCCURRED EX-US WERE BEING ASSESSED FOR MDR REPORTABILITY WITHIN THE UNITED STATES. AS A RESULT, ALL POTENTIALLY CRITICAL COMPLAINTS (US AND EX-US) FILED GOING BACK TO 01-JAN-2008 WERE REASSESSED TO DETERMINE IF ANY OF THOSE CASES REPRESENTED A MDR REPORTABLE EVENT. DURING THE RETROSPECTIVE REVIEW, THIS EVENT WAS IDENTIFIED AS BEING MDR REPORTABLE. WE ARE TAKING APPROPRIATE INTERNAL CORRECTIVE ACTIONS TO PREVENT RECURRENCE OF LATE FILINGS.--------------GC-0330649

    Description of Event or Problem · 1

    A CUSTOMER SITE HAD THEIR COBAS AMPLIPREP INSTRUMENT SERVICED ON 11-FEB-2010. DURING THE INSTRUMENT SERVICE, A FIELD SERVICE REPRESENTATIVE CHANGE THE COBAS AMPLIPREP INSTRUMENT R-TIPS, O-RINGS AND SYRINGE UNITS. SUBSEQUENT TO THE INSTRUMENT SERVICE, THE CUSTOMER SITE PERFORMED A TEST RUN TO VERIFY ASSAY PERFORMANCE. DURING THIS TEST RUN, THE CUSTOMER OBSERVED DISCREPANT COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, US-IVD RESULTS. THE TEST RUN WAS PERFORMED WITH PREVIOUSLY TESTED PATIENT SAMPLES; SAMPLES WERE NOT BEING TESTED FOR DIAGNOSTIC PURPOSES, AND THEREFORE, THERE WAS NO IMPACT ON PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST TEST, HIV DETECTION MZF ROCHE MOLECULAR SYSTEMS M08867

    Patients

    Seq Age Sex Outcome Treatment
    1