BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-04462

    MDR report key: 5210335 · Received November 9, 2015

    Report

    Report Number
    1823260-2015-04462
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 20, 2015
    Report Date
    November 18, 2015
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. FROM THE PROVIDED DATA, A GENERAL REAGENT OR INSTRUMENT ISSUE WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE B-SUBUNIT (HCG+B) RESULTS FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS >10000 MIU/ML. THE SAMPLE WAS RETESTED WITH A 1:100 ANALYZER DILUTION AND RESULT WAS 22671 MIU/ML. THIS DID NOT MATCH THE PATIENT'S PREVIOUS RESULT OF 89000 MIU/ML FROM (B)(6) 2015. THE CUSTOMER FOLLOWED UP WITH THE PATIENT'S DOCTOR AND CONFIRMED THE PATIENT HAD NOT MISCARRIED. THE CUSTOMER REPEATED THE SAME SAMPLE WITH A 1:100 ANALYZER DILUTION AND THE RESULT WAS 50399 MIU/ML. THE CUSTOMER THEN PERFORMED A MANUAL 1:100 DILUTION AND THE RESULT WAS 122700 MIU/ML. THIS RESULT WAS BELIEVED TO BE MORE IN LINE WITH THE PATIENT'S CLINICAL PROFILE. NO ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 18742803. THE EXPIRATION DATE WAS 11/30/2016. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DUPLICATE THE ISSUE. HE CHECKED THE ADJUSTMENT OF THE SAMPLE POSITION, MIXING, REAGENT PROBES AND SIPPERS. HE FOUND THE PINCH VALVE TUBINGS WERE OK. HE ADJUSTED THE PROBE VOLTAGE, PERFORMED PREVENTIVE MAINTENANCE AND INSPECTIONS, AND REPLACED THE SEALS AND PINCH VALVE TUBINGS. HE RAN PERFORMANCE TESTING AND THE CUSTOMER RAN CALIBRATIONS AND QC WHICH WERE WITHIN SPECIFICATION.

    Patients

    Seq Age Sex Outcome Treatment
    1 035 YR