BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH 930 ANALYZER

    MDR report key: 10184078 · Received June 23, 2020

    Report

    Report Number
    2432235-2020-00332
    Event Type
    Malfunction
    Date Received
    June 23, 2020
    Date of Event
    May 27, 2020
    Report Date
    August 11, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414002163
    PMA / PMN Number
    K151767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2020-00332 ON (B)(6) 2020. ADDITIONAL INFORMATION (B)(6) 2020: THE CUSTOMER PROVIDED ADDITIONAL INFORMATION, AND SECTION B6 IS UPDATED. THE CUSTOMER INFORMED SIEMENS THAT AN EXCHANGE TRANSFUSION (ET) IS THE FINAL TREATMENT FOR BABIES WITH SEVERE NEONATAL JAUNDICE TO AVOID KERNICTERUS COMPLICATIONS. THE CUSTOMER PERFORMED THE ET BECAUSE THE TOTAL BILIRUBIN_2 (TBIL_2) RESULT FROM ATELLICA CH 930 ANALYZER WAS ELEVATED. THE CUSTOMER NOTED THAT THE TOTAL SERUM BILIRUBIN (TSB) IS A GOLD STANDARD FOR DETECTING THE LEVEL OF HYPERBILIRUBINEMIA. NEONATAL JAUNDICE (NNJ) CASES ARE REFERRED FOR HOSPITAL ADMISSION FOR FURTHER MANAGEMENT OF NNJ. TSB LEVEL SERVES AS A GUIDELINE OR INDICATION TO DECIDE THE RIGHT TREATMENT, WHETHER IT IS PHOTOTHERAPY OR ET FOR NNJ BABIES. REGARDING THE DILUTION FACTOR (X2), USED WITH SAMPLE ID (B)(4), THE CUSTOMER INFORMED THAT ATELLICA CH 930 TBIL_2 RESULTS THAT ARE >300 UMOL/L PERFORM AN ONBOARD AUTO DILUTION OF A FACTOR OF 1:2. THE TBIL_2 RESULT OBTAINED FOR SAMPLE ID (B)(4), BEFORE THE AUTO DILUTION, WAS 530 UMOL/L. THE ATELLICA CH 930 ANALYZER IS OPERATING WITHIN SPECIFICATIONS, AND THE CUSTOMER IS OPERATIONAL.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND INFORMED THE PATIENT SAMPLE WAS FIRST COLLECTED IN A CAPILLARY TUBE AND TESTED ON AN ALTERNATE PLATFORM AT A DIFFERENT SITE. THE CUSTOMER INFORMED THAT ON THE SAME DAY, A PROPER BLOOD COLLECTION OF THE NEONATE BLOOD SAMPLE WAS OBTAINED ON A BABY TUBE AND SENT FOR TESTING ON THE ATELLICA CH 930 ANALYZER. THE CUSTOMER INFORMED THAT THE PHYSICIAN(S) ALLEGED THAT THE RESULT OBTAINED ON THE ALTERNATE PLATFORM IS CLOSER AND RELATES TO THE VISUAL ASSESSMENT OF KRAMER'S RULE. SIEMENS EVALUATED THE INFORMATION PROVIDED, AND THE TOTAL BILIRUBIN_2 (TBIL_2) QUALITY CONTROLS (QC) WERE IN RANGE AND CONSISTENT WITH BIORAD PEER-GROUP QC DATA. SIEMENS IS INFORMED THAT THE SAMPLE WAS INITIALLY RUN ON (B)(6) 2020 AT APPROXIMATELY 3:30 P.M. USING A BILIRUBINOMETER METHODOLOGY, AND THE SAMPLE WAS NOT FLAGGED FOR HEMOLYSIS. THE NEONATE'S TOTAL BILIRUBIN RESULT FROM THE BILIRUBINOMETER WAS ABOVE THE REFERENCE RANGE FOR THE BILIRUBINOMETER FOR A FULL-TERM BABY. THE NEONATE WAS SENT TO THE HOSPITAL FOR FURTHER EVALUATION AND REDRAWN APPROXIMATELY 6.5 HOURS LATER AT THE HOSPITAL AT APPROXIMATELY 10:00 P.M. AND RUN ON THE ATELLICA CH 930 ANALYZER USING THE TOTAL BILIRUBIN_2 (TBIL_2) VANADATE METHODOLOGY. THE ANALYZER REPORTED AN INITIAL RESULT OF 530.8 UMOL/L, AND THE OPERATOR PERFORMED A X2 MANUAL DILUTION AND OBTAINED A RESULT OF 497.1 UMOL/L. THE NEONATE'S TBIL_2 RESULT FROM THE ATELLICA ANALYZER WAS ALSO ABOVE THE NEONATAL REFERENCE RANGE FOR THE ATELLICA TBIL_2 ASSAY FOR A 3-5 DAY OLD NEONATE. SIEMENS COMPLETED THE INVESTIGATION AND DETERMINED THE PROBABLE CAUSE OF A DISCORDANT TBIL_2 RESULT FOR A NEONATAL SAMPLE IS DUE TO THE METHODOLOGY DIFFERENCES, AND THE 6.5 HOUR TIME DIFFERENCE BETWEEN SAMPLE DRAWS. THE RESULTS REPORTED BY THE CUSTOMER WERE HIGH WHEN COMPARED TO THEIR RESPECTIVE REFERENCE RANGES, AND ARE CLINICALLY EQUIVALENT. THERE IS NO REAGENT ISSUE, AND THE ANALYZER IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE WAS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER INFORMED THAT A DISCORDANT FALSELY ELEVATED TOTAL BILIRUBIN_2 (TBIL_2) RESULT WAS OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE DISCORDANT RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN(S). THE CUSTOMER INFORMED THAT THE RESULT OBTAINED ON THE ATELLICA WAS HIGHER THAN AN INITIAL RESULT OBTAINED ON AN ALTERNATE PLATFORM. THE CUSTOMER INFORMS THE RESULT OBTAINED ON THE ALTERNATE PLATFORM WAS REPORTED TO THE PHYSICIAN(S) AND CONSIDERED THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED TBIL_2 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647509 ATELLICA CH 930 ANALYZER ATELLICA CH 930 ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930 ANALYZER 00630414002163

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DA