BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 18594320 · Received January 29, 2024

    Report

    Report Number
    3005094123-2024-00035
    Event Type
    Injury
    Date Received
    January 29, 2024
    Date of Event
    December 28, 2023
    Report Date
    February 8, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    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. E1 FACILITY NAME COMPLETE INFORMATION: (B)(6) HOSPITAL. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P51-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P51-21 / 31 ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. REVIEW OF ALL THE INFORMATION PROVIDED BY THE CUSTOMER WAS REVIEWED. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. A TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. IN-HOUSE ACCURACY TESTING WAS COMPLETED USING PANELS WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED KIT STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. THE CROSS FUNCTIONAL TEAM (CFT) AGREED THAT THE CUSTOMER DID NOT FOLLOW PRODUCT LABELING AS REQUIRED, THEREFORE THIS EVENT IS DEEMED INCORRECT USE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I TOTAL ¿-HCG REAGENT LOT 55509UD01 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.CORRECTED INFORMATION IN SECTION B3 - DATE OF THE EVENT

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOTAL -HCG RESULTS FOR A 7-YEAR-OLD FEMALE PEDIATRIC PATIENT DIAGNOSED WITH SEXUAL PRECOCITY. THE CUSTOMER REPORTED SINCE (B)(6), 2023 THE PATIENT HAD SEVERAL B-HCG TESTS WITH RESULTS RANGING BETWEEN 7.3 MIU/ML -10 MIU/ML; THEREFORE, THE PATIENT WAS HOSPITALIZED. THE PATIENT HAD THE FOLLOWING TESTS WHILE HOSPITALIZED AS A RESULT OF THE B-HCG RESULTS: PLAIN AND ENHANCED MRI SCAN OF THE PITUITARY GLAND, ABDOMINAL B-MODE ULTRASOUND, PLAIN CT SCAN OF THE WHOLE ABDOMEN, AND A PLAIN CT SCAN OF THE CHEST THAT ALL RESULTED IN NO ABNORMALITIES. ADDITIONALLY, THE PATIENT UNDERWENT A LUMBAR PUNCTURE TO TEST THE CEREBROSPINAL FLUID FOR B-HCG AND THE RESULT WAS NEGATIVE. THE RESULT ON ROCHE WAS < 0.1 (NEGATIVE) THE CUSTOMER REPORTED THE PATIENT WAS DISCHARGED HOME FROM THE HOSPITAL AND THERE IS NO REPORTED PATIENT HARM AS A RESULT. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOTAL ¿-HCG RESULTS FOR A 7-YEAR-OLD FEMALE PEDIATRIC PATIENT DIAGNOSED WITH SEXUAL PRECOCITY. THE CUSTOMER REPORTED SINCE DECEMBER 28, 2023 THE PATIENT HAD SEVERAL B-HCG TESTS WITH RESULTS RANGING BETWEEN 7.3 MIU/ML -10 MIU/ML; THEREFORE, THE PATIENT WAS HOSPITALIZED. THE PATIENT HAD THE FOLLOWING TESTS WHILE HOSPITALIZED AS A RESULT OF THE B-HCG RESULTS: PLAIN AND ENHANCED MRI SCAN OF THE PITUITARY GLAND, ABDOMINAL B-MODE ULTRASOUND, PLAIN CT SCAN OF THE WHOLE ABDOMEN, AND A PLAIN CT SCAN OF THE CHEST THAT ALL RESULTED IN NO ABNORMALITIES. ADDITIONALLY, THE PATIENT UNDERWENT A LUMBAR PUNCTURE TO TEST THE CEREBROSPINAL FLUID FOR B-HCG AND THE RESULT WAS NEGATIVE. THE RESULT ON ROCHE WAS < 0.1 (NEGATIVE) THE CUSTOMER REPORTED THE PATIENT WAS DISCHARGED HOME FROM THE HOSPITAL AND THERE IS NO REPORTED PATIENT HARM AS A RESULT. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533548 ALINITY I TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 55509UD01

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Female Other ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)