BEUDAMED
    FDA Adverse Event Summary report: N

    RAPIDPOINT 500

    MDR report key: 4902085 · Received July 9, 2015

    Report

    Report Number
    1217157-2015-00093
    Date Received
    July 9, 2015
    Date of Event
    June 16, 2015
    Report Date
    June 22, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KQO
    PMA / PMN Number
    K113216
    Removal / Correction Number
    Z-1253-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS REVIEWED DATA SENT BY CUSTOMER. DATE: (B)(6), TIME: 07:19, THB RESULT: >25.0, NBILI RESULT: 178 UMOL/L. (B)(6), 11:19, NOT ORDERED, 186 UMOL/L. INVESTIGATION RESULT: CUSTOMER IS APPLYING A CORRELATION COEFFICIENT TO THE NBILI RESULTS (SLOPE OF 0.865 AND OFFSET OF 0.000). THE NBILI RESULTS ON THE SAMPLES IN QUESTION WERE >205 UMOL/L (>12 MG/DL) BEFORE THE CORRELATION COEFFICIENTS WERE APPLIED. ONCE THE CORRELATION COEFFICIENTS WERE APPLIED, THE NBILI RESULTS WERE BOTH < 205 UMOL/L (<12 MG/DL). THE FLAGGING OF NBILI AS "QUESTION RESULTS" FOR CASES WHERE THE THB IS >25 G/DL AND NBILI IS < 205 UMOL/L (<12 MG/DL) IS PERFORMED WITHOUT THE CORRELATION COEFFICIENTS BEING APPLIED TO THE RESULTS. THIS ALGORITHM ONLY APPLIES TO THE MEASURED THB AND NBILI RESULTS, NOT TO ANY CUSTOMER CORRELATED VALUES. THE NBILI RESULTS FOR BOTH SAMPLES IN QUESTION WERE >12.0 MG/DL (>205 UMOL/L) BEFORE THE CORRELATION COEFFICIENTS WERE APPLIED SO THE RESULTS WERE CORRECTLY NOT FLAGGED AS QUESTION VALUES. UFSN 32258 NEONATAL BILIRUBIN REPORTING WHEN THB IS OUT OF RANGE HIGH, UNDER ACTIONS TO BE TAKEN BY THE CUSTOMER, STATES THAT IF THE ANALYZER INDICATES THE THB RESULT IS OUT OF RANGE HI AND AN NBILI RESULT IS REPORTED, DO NOT USE THE NBILI RESULT REPORTED FROM THE ANALYZER. CUSTOMER SHOULD NOT HAVE REPORTED NBILI RESULT TO PHYSICIAN AS PER UFSN. THE EVENT HAD OCCURRED DUE TO AN OPERATOR ERROR.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT INSTRUMENT REPORTED NBIL RESULT 178 UMOL/L WHEN THB RESULT WAS OVER 25 G/DL. CUSTOMER INDICATED THAT THIS WAS MISMATCH TO UFSN (Z-1253-2015) WHICH STATES THAT IF THE THB RESULT > 25 G/DL AND NBILI RESULTS <=205 UMOL/L, NBILI REPORT SHOULD BE REPORTED AS "----?". THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446221 RAPIDPOINT 500 RP 500 KQO SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1