BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 15906578 · Received December 2, 2022

    Report

    Report Number
    3005094123-2022-00282
    Event Type
    Injury
    Date Received
    December 2, 2022
    Date of Event
    October 30, 2022
    Report Date
    January 11, 2023
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE LIKELY CAUSE LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON LOT 42504UD01, WHICH DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF ALINITY I TOTAL SS-HCG REAGENTS IN THE FIELD WAS REVIEWED USING WORLDWIDE FIELD DATA. THE MEDIAN VALUE OF THE NEGATIVE POPULATION FOR THE COMPLAINT LOT NUMBER(S) ARE WITHIN THE ESTABLISHED LIMITS. LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. AS PER THE INTENDED USE SECTION OF THE PACKAGE INSERT ¿THE ALINITY I TOTAL HCG ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) USED FOR THE QUANTITATIVE AND QUALITATIVE DETERMINATION OF BETA-HUMAN CHORIONIC GONADOTROPIN (HCG) IN HUMAN SERUM AND PLASMA FOR THE EARLY DETECTION OF PREGNANCY ON THE ALINITY I ANALYZER¿. AS PER THE LIMITATIONS OF THE PROCEDURE SECTION ¿THE ALINITY I TOTAL HCG ASSAY IS CLEARED FOR USE IN THE EARLY DETECTION OF PREGNANCY ONLY. IT IS NOT APPROVED FOR ANY OTHER USES SUCH AS TUMOR MARKER SCREENING, TUMOR MARKER MONITORING, ETC. AND IT SHOULD NOT BE PERFORMED FOR ANY OTHER USES.¿ BASED ON THE INFORMATION PROVIDED IN THE COMPLAINT TEXT, IT WAS DETERMINED THAT ABNORMAL USE OR USE ERROR, SPECIFICALLY ¿OFF-LABEL USE¿, OCCURRED FOR THE ALINITY I TOTAL SS-HCG ASSAY. BASED ON ALL REVIEWED DATA, WE CONCLUDE THAT THERE IS NO PRODUCT DEFICIENCY WITH THE ALINITY I TOTAL SS-HCG REAGENT IDENTIFIED IN THIS COMPLAINT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I TOTAL B-HCG RESULTS WHEN COMPARED TO RESULTS FROM ANOTHER HOSPITAL FOR A 10-YEAR-OLD MALE PATIENT. IN (B)(6) 2022, THE PATIENT WAS TESTED FOR HCG DUE TO PUBERTY CHANGES. AFTER THE RESULT WAS GREATER THAN THE REFERENCE RANGE AND FOLLOW-UP RESULTS REMAINED HIGH, THE PATIENT WAS ADMITTED FOR A COMPREHENSIVE PHYSICAL EXAMINATION. SINCE NO OBVIOUS CAUSE OF DISEASE WAS FOUND, THE CLINICAL PHYSICIAN ORDERED AN ENHANCED CT SCAN, SUSPECTED A PITUITARY GLAND-RELATED DISEASE, AND CONDUCTED A CEREBROSPINAL FLUID PUNCTURE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2022 ALINITY I TOTAL B-HCG 23.4 MIU/ML. (B)(6) 202211/13 ALINITY I TOTAL B-HCG 23.9 MIU/ML. (B)(6) 2022 ALINITY I TOTAL B-HCG 25.4 MIU/ML. THE PATIENT WAS TESTED AT ANOTHER HOSPITAL (SIEMENS PLATFORM), AND THE RESULT WAS <2 (REFERENCE RANGE: 0-5 MIU/ML). THE RETEST RESULT WAS CONSISTENT. THE USER USED PEG6000 PRECIPITATION ON THE SAMPLE, AND THE RESULT WAS <2 MIU/ML. THE PATIENT UNDERWENT A CEREBRAL SPINAL FLUID PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395634 ALINITY I TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA A.I.D.D LONGFORD 42504UD01

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male Disability ALNTY I PROCESSING MODU, 03R65-01, AI05227| ALNTY I PROCESSING MODU, 03R65-01, AI05227