BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MG2 MAGNESIUM GEN.2

    MDR report key: 6151178 · Received December 7, 2016

    Report

    Report Number
    1823260-2016-01914
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 18, 2016
    Report Date
    December 7, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGJ
    PMA / PMN Number
    K954992
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ANALYZER SWITCHED TO A STANDBY MG2 MAGNESIUM GEN.2 REAGENT PACK AND THE TECH NOTICED SEVERAL LOW RESULTS WERE GENERATED. THE CUSTOMER USED COBAS 6000 C (501) MODULE SERIAL NUMBER (B)(4). THE SAMPLES WERE REPEATED ON A DIFFERENT COBAS C501 ANALYZER AND THE RESULTS DID NOT MATCH. DATA WAS PROVIDED FOR FOUR PATIENT SAMPLES. SAMPLE 1: ORIGINAL RESULT WAS 0.7 MG/DL AND THE REPEAT RESULT WAS 1.7 MG/DL. SAMPLE 2: ORIGINAL RESULT WAS 0.6 MG/DL AND THE REPEAT RESULT WAS 1.6 MG/DL. SAMPLE 3: ORIGINAL RESULT WAS 1.0 MG/DL AND THE REPEAT RESULT WAS 2.0 MG/DL. SAMPLE 4: ORIGINAL RESULT WAS 0.9 MG/DL AND THE REPEAT RESULT WAS 1.9 MG/DL. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE ORIGINAL RESULTS WERE RELEASED FROM THE LABORATORY, BUT CORRECTED REPORTS WERE SENT WITHIN A FEW HOURS. THERE WAS NO ADVERSE EVENT AS THE DOCTOR WAS CONTACTED PRIOR TO ANY TREATMENT. THE ORIGINAL RESULTS FOR OTHER ASSAYS FOR THE SAMPLES IN QUESTION MATCHED THE HISTORICAL RESULTS FOR THE PATIENTS AND WERE NOT REPEATED. THERE WERE NO ISSUES WITH ANY OTHER ASSAYS. THE TECH RECALIBRATED THE SUSPECT MAGNESIUM REAGENT CASSETTE AND RAN QC WHICH WAS ACCEPTABLE. THE REMAINING TESTS USING THIS REAGENT CASSETTE WERE ALL ACCEPTABLE. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE. HE RAN PRECISION TESTING WITH ALL RESULTS ON THE MEAN. HE VERIFIED THE OPERATIONAL AND MECHANICAL CHECKS PASSED. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. AS THE ISSUE DID NOT REOCCUR WITH THE OTHER REAGENT CASSETTES, A CUSTOMER HANDLING ISSUE WITH THE SUSPECT REAGENT CAUSING CONTAMINATION OR DENATURATION WAS THE MOST LIKELY CAUSE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801265 MG2 MAGNESIUM GEN.2 PHOTOMETRIC METHOD, MAGNESIUM JGJ ROCHE DIAGNOSTICS NA 16186501

    Patients

    Seq Age Sex Outcome Treatment
    1