BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 3386963 · Received October 4, 2013

    Report

    Report Number
    1823260-2013-06096
    Event Type
    Malfunction
    Date Received
    October 4, 2013
    Date of Event
    September 6, 2013
    Report Date
    October 4, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF QUESTIONABLE RESULTS ON TWO PATIENT SAMPLES WHEN TESTED FOR HCG+SS - INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS- SUBUNIT. THE CUSTOMER PROVIDED DATA FOR APPROXIMATELY 690 PATIENTS FOR MULTIPLE ASSAYS. OF THE DATA PROVIDED ONLY THE TWO HCG+SS RESULTS WERE ERRONEOUS. PATIENT 1 WAS (B)(6) PREGNANT. THE INITIAL HCG+SS RESULT WAS 79.6 MIU/ML. ON THE SAME DAY THE PATIENT HAD AN ULTRASOUND THAT SHOWED THE BABY WAS GROWING WELL WITH NORMAL DEVELOPMENT. ON (B)(6) 2013 THE DOCTOR REQUESTED SAMPLE BE RETESTED. THE REPEAT HCG+SS WAS 94604 MIU/ML WHEN TESTED AT A 1:20 DILUTION. THE TEST WAS REPEATED AGAIN WITH RESULTS OF 94608 AND 94687 MIU/ML. THE PATIENT WAS NOT HARMED BY ANY ACTION TAKEN. THE FIELD ENGINEER CHECKED THE MECHANISM POSITION AND SAMPLE PROBE ASPIRATION AND BOTH WERE WORKING CORRECTLY. PERFORMANCE TESTING WAS PERFORMED WITH OK RESULTS. ON (B)(6) 2013 THE CUSTOMER EXPERIENCED A SECOND OCCURRENCE OF THE ISSUE. THE SAMPLE FOR PATIENT 2 YIELDED AN HCG+SS OF 1170 MIU/ML. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 33.50 AND 1197 MIU/ML. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION REGARDING WHICH RESULTS WERE REPORTED OUTSIDE THE LABORATORY OR IF THE PATIENT WAS ADVERSELY AFFECTED BY THE EVENT. THE FIELD ENGINEER PERFORMED PRECISION TESTING AND NOTED THE VOLUME OF PRECLEAN M INJECTED INTO THE CUPS WAS INCONSISTENT AND SOMETIMES INSUFFICIENT. HE FOUND AN OBSTACLE IN THE PINCH VALVE AND CLEANED IT. HE ALSO FOUND A BENT PRECLEAN NEEDLE. THE NEEDLE WAS FIXED. PRECISION TESTING WAS PERFORMED. NO MORE CLINICAL COMPLAINTS WERE RECEIVED. THE INSTRUMENT OPERATOR WAS INSTRUCTED TO CONTINUE MONITORING SAMPLE MEASUREMENT. THE INVESTIGATION DID NOT DETERMINE A SPECIFIC ROOT CAUSE. A GENERAL REAGENT ISSUED WAS NOT FOUND. IT WAS NOTED THE CUSTOMER WAS NOT USING THE RECOMMENDED SAMPLE RACK ADAPTERS. HARDWARE ISSUES WERE CORRECTED. THE SERVICE ACTIONS RESOLVED THE ISSUE. THE LOT NUMBER OF HCG+SS REAGENT IN USE WAS 170870; THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502659 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS E MODULE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 024 YR