BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-02642

    MDR report key: 7040585 · Received November 17, 2017

    Report

    Report Number
    1823260-2017-02642
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Date of Event
    October 27, 2017
    Report Date
    January 4, 2018
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE ANALYZERS ALARM LOG SHOWED MULTIPLE OCCURRENCES OF "ABNORMAL ASPIRATION" ALARMS ON THE DAY OF EVENT. THIS INDICATES THAT A POTENTIAL ROOT CAUSE COULD HAVE BEEN RELATED TO PRE-ANALYTICAL ISSUES. BASED ON QC RESULTS A GENERAL INSTRUMENT ISSUES IS NOT LIKELY. THERE WAS NO INDICATION OF A REAGENT PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF A QUESTIONABLE RESULT FOR 1 PATIENT TESTED FOR A1C-3 TINA-QUANT HEMOGLOBIN A1C GEN.3 (HBA1C) ON A COBAS 8000 C 502 MODULE. TWO SEPARATE DOCTORS ORDERED HBA1C TESTING ON THE SAME PATIENT SO THE PATIENT HAD TWO SAMPLES DRAWN AT THE SAME TIME. FOR SAMPLE A THE INITIAL HBA1C RESULT WAS 6.7% WHILE SAMPLE B¿S INITIAL HBA1C RESULT WAS 5.8%. THE SAMPLE B RESULT OF 5.8% WAS REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR QUESTIONED THE REPORTED HBA1C RESULT DUE TO THE DIFFERENCES BETWEEN SAMPLE A AND SAMPLE B. SAMPLE B WAS RETESTED ON (B)(6) 2017 AND AN HBA1C RESULT OF 6.8% WAS OBTAINED. THE RETEST RESULT OF SAMPLE B WAS DEEMED TO BE CORRECT AND A CORRECTED REPORT WAS ISSUED. THE PATIENT WAS NOT TREATED BASED ON THE ORIGINAL RESULT. THERE WAS NO ADVERSE EVENT. THE SAMPLES WERE ALIQUOTED BY A MODULAR PRE-ANALYTICS ANALYZER. THE HBA1C REAGENT LOT WAS 253327 WITH AN EXPIRATION DATE OF 31-JAN-2019. THE FIELD ENGINEERING SPECIALIST WAS UNABLE TO FIND A CAUSE. HE CHECKED THE OPERATION OF THE INSTRUMENT. THE CUSTOMER RAN CALIBRATION, QC, AND PRECISION TESTING WHICH ALL PASSED.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR