BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM ANTI-HBS2 (AHBS2) ASSAY

    MDR report key: 10796029 · Received November 5, 2020

    Report

    Report Number
    1219913-2020-00515
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    January 6, 2020
    Report Date
    December 28, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    UDI-DI
    00630414597836
    PMA / PMN Number
    P100039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 1219913-2020-00515 WAS FILED ON 05-NOV-2020 FOR A FALSE POSITIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) PATIENT RESULT. 04-DEC-2020 ADDITIONAL INFORMATION: THE CUSTOMER HAS PROVIDED THE FOLLOWING INFORMATION FOR THE 06-JAN-2020 SAMPLE: SAMPLE TYPE: SERUM (PRIMARY TUBE) SAMPLE COLLECTION: DRY TUBE WITH GEL BY VACUTAINER SST CENTRIFUGE LOCATION: OFFSITE CLOTTING TIME: 30 MINUTES CENTRIFUGE GRAVITATIONAL FORCE (G) /TIME: 2000G FOR 10 MINUTES SIEMENS HAS CONCLUDED THE INVESTIGATION. THE PATIENT WAS NOT VACCINATED FOR HEPATITIS B, AND THE CUSTOMER WAS NOT ABLE TO PROVIDE THE PATIENT'S MEDICAL STATUS OR A LIST OF MEDICATIONS/SUPPLEMENTS. THE PATIENT SAMPLE IN NOT AVAILABLE FOR FURTHER INVESTIGATION BY SIEMENS. THE CUSTOMER'S BLOOD COLLECTION TUBE HANDLING APPEARS TO BE IN ALIGNMENT WITH THE MANUFACTURER'S RECOMMENDATIONS, HOWEVER IF THE CENTRIFUGE USED HAD A FIXED ANGLE ROTOR, IT IS RECOMMENDED BY THE BLOOD COLLECTION TUBE MANUFACTURER TO CENTRIFUGE GEL TUBES FOR 15 MINUTES. IF THE PATIENT WAS TAKING BLOOD THINNERS (UNKNOWN), THE SAMPLE MAY HAVE POTENTIALLY REQUIRED MORE THAN 30 MINUTES TO CLOT. THE CUSTOMER STATED THAT BLOOD SAMPLES ARE CENTRIFUGED OFFSITE AND THEN TRANSPORTED TO THE LABORATORY FOR TESTING. THE TRANSPORTATION AFTER CENTRIFUGATION MAY POTENTIALLY INCREASE THE INCIDENCE OF PARTICULATE MATTER IN THE SAMPLES. (E.G. RESUSPENSION OF SOMETHING WHICH OTHERWISE WOULD REMAIN SETTLED).THE CLINICAL SENSITIVITY AND SPECIFICITY SECTION OF THE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) INSTRUCTIONS FOR USE (IFU) (10995277, REVISION 04, 2019-07) LISTS THE 95% CONFIDENCE INTERVAL (CI) FOR RESOLVED RELATIVE SPECIFICITY AS 98.34% - 99.88% SO A CERTAIN NUMBER OF FALSE POSITIVE RESULTS CAN BE EXPECTED FOR THIS ASSAY. A REVIEW OF INTERNAL DATA INDICATES ATELLICA IM AHBS2 REAGENT LOT 123 IS PERFORMING AS INTENDED. THE CAUSE OF THE FALSE POSITIVE RESULTS SEEN BY THE CUSTOMER WHEN USING ATELLICA IM AHBS2 REAGENT LOT 123 IS UNKNOWN, HOWEVER PRE-ANALYTICAL FACTORS, A SAMPLE ISSUE, OR NORMAL ASSAY PERFORMANCE CANNOT BE RULED OUT. BASED ON THE INVESTIGATION, A PRODUCT PROBLEM WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL. THE ASSAY IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT DISCORDANT, FALSE REACTIVE ATELLICA IM (B)(6) RESULT. THE CUSTOMER'S QUALITY CONTROL RESULTS WERE ACCEPTABLE WHEN TESTING WAS PERFORMED. SIEMENS IS INVESTIGATING. THE INSTRUCTIONS FOR USE (IFU) UNDER THE INTERPRETATION OF RESULTS SECTION STATES THE FOLLOWING: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS."

    Description of Event or Problem · 1

    A FALSE REACTIVE ATELLICA IM (B)(6) RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT AND REPORTED TO THE PHYSICIAN(S). THE REACTIVE (B)(6) RESULT WAS CONSIDERED DISCORDANT COMPARED TO A NONREACTIVE (B)(6) NEW SAMPLE RESULT RUN ON A NEW REAGENT LOT. THE ORIGINAL SAMPLE WAS RETESTED ON THE NEW REAGENT LOT AND THE (B)(6) RESULT WAS NONREACTIVE. THE NONREACTIVE (B)(6) RETEST RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECTED RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, REACTIVE ATELLICA IM (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256519 ATELLICA IM ANTI-HBS2 (AHBS2) ASSAY AHBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 123 00630414597836

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR