BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 3082153 · Received April 29, 2013

    Report

    Report Number
    1823260-2013-02590
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT FOR THIS EVENT STATED THAT THE INITIAL HBA1C RESULT WAS 3.4%. NEW INFORMATION WAS RECEIVED FROM THE CUSTOMER. THE CUSTOMER COULD NOT CONFIRM IF THE FINAL CALCULATED HBA1C RESULT WAS 3.4% OR IF THE 3.4 WAS AN ABSOLUTE VALUE USED IN CALCULATION OF THE FINAL HBA1C RESULT. ALL SAMPLE REPEATS WERE PERFORMED ON (B)(6) 2013. THE CUSTOMER PROVIDED NEW INFORMATION STATING THAT THE HBA1C VALUE COULD NOT BE CALCULATED FOR THE FIRST REPEAT DONE AFTER ALLOWING THE SAMPLE TO SETTLE. THIS VALUE WAS INITIALLY PROVIDED AS 0.0 %.

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION PROVIDED FOR INVESTIGATION. ADDITIONAL INFORMATION AND PATIENT SAMPLE ARE NOT AVAILABLE FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR HEMOGLOBIN A1C (HBA1C). THE SAMPLE INITIALLY RESULTED AS 3.4 % ACCOMPANIED BY A DATA FLAG AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL VALUE WAS QUESTIONED BECAUSE THE PATIENT HAD A HIGH GLUCOSE RESULT "IN THE 500'S" MG/DL. THE CUSTOMER ALLOWED THE SAMPLE TO SETTLE AND REPEATED IT ON INTEGRA 800 SERIAL NUMBER (B)(4) RESULTING WITH AN HBA1C VALUE OF 0.0 % ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED 1:1 AND REPEATED ON INTEGRA 800 SERIAL NUMBER (B)(4) RESULTING AS 17.3%. THE CUSTOMER DID NOT BELIEVE ANY VALUES TO BE CORRECT AND REQUESTED A RE-DRAW OF THE PATIENT. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE HBA1C REAGENT LOT NUMBER WAS 66927201 WITH AN EXPIRATION DATE OF 01/31/2014. THE CUSTOMER DECLINED A SERVICE VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185486 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR