BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBAS TAQSCREEN MPX TEST FOR USE ON THE COBAS S 201 SYSTEM

    MDR report key: 1831654 · Received September 13, 2010

    Report

    Report Number
    2243471-2010-00035
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 21, 2009
    Report Date
    September 29, 2010
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MTL
    PMA / PMN Number
    BL 125255
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE INFORMATION: UPDATED TO REFLECT THE KIT LOT AND EXPIRY. DEVICE EVALUATED BY MANUFACTURER: UPDATED TO REFLECT "NO - DEVICE PROBLEM ALREADY KNOWN - NO EVALUATION NECESSARY" DEVICE MANUFACTURE DATE: UPDATED TO REFLECT DEVICE STOCK DATE. EVALUATION CODES: UPDATED TO REFLECT THE OUTCOME OF THE COMPLAINT INVESTIGATION. METHOD = ANALYSIS OF DONOR SAMPLE. MANUFACTURER NARRATIVE: AN INTERNAL INVESTIGATION INTO THIS ISSUE WAS PERFORMED. THE CUSTOMER'S OBSERVATION OF A FALSE NEGATIVE RESULT WITH THE COBAS® TAQSCREEN MPX TEST WAS REPRODUCED WITH THE DONOR SPECIMEN. SEQUENCING ANALYSIS OF DONOR SPECIMEN WAS PERFORMED AND THE FOLLOWING WAS IDENTIFIED: THE DONOR SPECIMEN IS (B)(6), SUBTYPE B. -THERE ARE MISMATCHES TO A PRIMER FOR THE COBAS® TAQSCREEN MPX TEST THAT ARE NOT DETECTED BY THE TEST. THE MISMATCHES OBSERVED WITH THIS DONOR SPECIMEN ARE UNIQUE COMPARED TO KNOWN SEQUENCES. AS SPECIFIED WITHIN THE COBAS® TAQSCREEN MPX TEST PRODUCT LABELING, "THOUGH RARE, MUTATIONS WITHIN THE HIGHLY CONSERVED REGION OF A VIRAL GENOME COVERED BY THE COBAS® TAQSCREEN MPX TEST PRIMERS AND/OR PROBE MAY RESULT IN FAILURE TO DETECT A VIRUS." THE COBAS® TAQSCREEN MPX TEST IS PERFORMING AS INTENDED AND WITHIN LABELING CLAIMS. THERE WAS NO MALFUNCTION OR NON-CONFORMANCE IDENTIFIED. (B)(4)

    Additional Manufacturer Narrative · 1

    THE DATA PROVIDED INDICATES THAT (B)(6) NEGATIVE RESULTS WERE REPRODUCIBLE WITH THE ROCHE COBAS® TAQSCREEN MPX TEST WITH DIFFERENT KIT BATCHES (NOTE: ALTHOUGH KIT BATCH INFORMATION WAS NOT PROVIDED, THE TIME LAPSE BETWEEN THE INITIAL TEST RUN AND THE REPEAT TEST RUN SUGGEST THAT DIFFERENT BATCHES WERE UTILIZED). THIS SUGGESTS THAT THE ISSUE IS NOT KIT BATCH RELATED. THE CURRENT HYPOTHESIS IS THAT THIS ISSUE IS THE RESULT OF MUTATIONS WITHIN THE VIRAL GENOME THAT RESULTED IN THE INABILITY OF THE COBAS® TAQSCREEN MPX TEST TO DETECT THE VIRUS. AS SPECIFIED WITHIN THE PRODUCT LABELING, "THOUGH RARE, MUTATIONS WITHIN THE HIGHLY CONSERVED REGIONS OF A VIRAL GENOME COVERED BY THE COBAS® TAQSCREEN MPX TEST PRIMERS AND/OR PROBE MAY RESULT IN FAILURE TO DETECT A VIRUS." THE DONOR SAMPLE IS BEING RETURNED TO ROCHE MOLECULAR SYSTEMS FOR SEQUENCE ANALYSIS AND THE OUTCOME OF THAT ANALYSIS, AND THE CONCLUSION OF THIS INVESTIGATION, WILL BE PROVIDED THROUGH A FOLLOW-UP REPORT. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE BLADE WAS BROKEN. NO PIECE FELL INTO THE PATIENT. THE SURGEON OPENED A SECOND DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    ON (B)(6)-2010, DONOR (B)(6). TESTED SEROLOGY AND NUCLEIC ACID POSITIVE FOR (B)(6) WITH THE ABBOT (B)(6)AG/AK COMBO TEST AND THE GFE BLUT MBH AUTOX-SYSTEM 2.0 (B)(6)-SINGLE-PCR TEST, RESPECTIVELY. THE BLOOD DONATION ASSOCIATED WITH THESE RESULTS WAS BLOCKED. DURING A RETROSPECTIVE REVIEW OF PREVIOUS DONATIONS FROM DONOR (B)(6)., TWO PREVIOUS DONATIONS WERE IDENTIFIED, (B)(6)-2009 AND (B)(6)-2009. THESE PREVIOUS DONATIONS WERE TESTED NEGATIVE WITH THE ROCHE COBAS® TAQSCREEN MPX TEST. THERE WAS NO SEROLOGY, OR ALTERNATIVE NUCLEIC ACID TESTING, INFORMATION PROVIDED; AT THIS TIME IT IS UNKNOWN IF ADDITIONAL TESTS WERE PERFORMED. THE CUSTOMER THEN RETESTED THE RETAINED BLOOD DONATIONS FROM (B)(6)-2009 AND (B)(6)2009. -THE DONATION FROM (B)(6)-2009 WAS NEGATIVE BY THE ABBOTT (B)(6)1/2 GO ANTI-(B)(6) TEST, THE INNOGENETICS INNO-LIA (B)(6) I/II SCORE BLOT TEST AND THE GFE BLUT MBH AUTOX-SYSTEM 2.0 (B)(6)-SINGLE-PCR TEST. -THE DONATION FROM (B)(6)-2009 WAS NEGATIVE BY THE ABBOTT (B)(6)1/2 GO ANTI-(B)(6) TEST, THE INNOGENETICS INNO-LIA (B)(6) I/II SCORE BLOT TEST, BUT WAS POSITIVE FOR (B)(6) BY THE GFE BLUT MBH AUTOX-SYSTEM 2.0 (B)(6)-SINGLE-PCR TEST. DUE TO THE POSITIVE RESULT FOR (B)(6) WITH THE DONATION FROM (B)(6)-2009, ADDITIONAL TESTING WAS PERFORMED WITH THE RETAIN MATERIAL. THE FOLLOWING RESULTS WERE GENERATED: -ROCHE COBAS® TAQSCREEN MPX TEST = DUPLICATE NEGATIVE FOR (B)(6). -GFE BLUT MBH AUTOX-SYSTEM 2.0 (B)(6)-SINGLE-PCR TEST = DUPLICATE POSITIVE FOR (B)(6). -ABBOTT M2000 (B)(6)-PCR TEST = 18,000 (B)(6)-1 RNA CP/ML -SIEMENS VERSANT® KPCR (B)(6)-PCR TEST = 2,600 (B)(6)-1 RNA CP/ML -QIAGEN ULTRASENS/RT-PCR = 9,300 (B)(6)-1 RNA CP/ML UPON GATHERING THESE DATA, THE CUSTOMER NOTIFIED THE RECIPIENT HOSPITAL AND REQUESTED A SEARCH TO TRANSFUSIONS OF THE IMPACTED MATERIAL. THE HOSPITAL INDICATED THAT ONE ERYTHROCYTE CONCENTRATION, FROM THE DONATION ON (B)(6)-2009, WAS TRANSFUSED INTO PATIENT (B)(6), WHO WAS IDENTIFIED AS A MALE, (B)(6). PATIENT (B)(6). TESTED ANTIBODY POSITIVE WITH AN (B)(6)-ANTIBODY TEST, BLOT AND (B)(6)-PCR; SPECIFIC TESTS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS TAQSCREEN MPX TEST FOR USE ON THE COBAS S 201 SYSTEM TEST, HIV DETECTION MTL ROCHE MOLECULAR SYSTEMS M01497

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other