BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1628664-2016-00231

    MDR report key: 5940320 · Received September 9, 2016

    Report

    Report Number
    1628664-2016-00231
    Event Type
    Malfunction
    Date Received
    September 9, 2016
    Report Date
    April 21, 2017
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS, A REVIEW OF LABELING AND INSTRUMENT SERVICE. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. SEVEN PARTS WERE REPLACED (REAGENT PROBE LN 01G47-03, REAGENT PROBE TUBING LN 01G47-02, SAMPLE PIPETTOR INNER TUBING PN 7-93238-01, R2 PIPETTOR INNER TUBING PN 7-93247-01, BELLOWS PN 2-89054-02, ICT PINCH VALVE TUBING PN 7-204068-01, R1 PIPETTOR INNER TUBING, PN 7-93246-01) AND INSTRUMENT MAINTENANCE WAS PERFORMED, AND THIS RESOLVED THE ISSUE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, THE ANALYZER PERFORMED AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE CONCLUSION CODE WAS CORRECTED TO (B)(4). THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THEREFORE, THE DEVICE WAS NOT PERFORMING AS INTENDED, HOWEVER, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY DEPRESSED SODIUM RESULTS FOR APPROXIMATELY 4 PATIENTS ON THE ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL AROUND 105, REPEATED IN THE NORMAL RANGE OF 136-145 MMOL/L (NO SPECIFIC DATA PROVIDED). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Patients

    Seq Age Sex Outcome Treatment
    1 LN 04P98-34 LOT UNKNOWN| SODIUM REAGENTS