BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TSH REAGENT KIT

    MDR report key: 12528709 · Received September 24, 2021

    Report

    Report Number
    3005094123-2021-00182
    Event Type
    Malfunction
    Date Received
    September 24, 2021
    Date of Event
    August 24, 2021
    Report Date
    October 6, 2021
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    JLW
    UDI-DI
    00380740131159
    PMA / PMN Number
    K983442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED FOR ALINITY I TSH REAGENT LOT 26158UD00. A REVIEW OF TICKETS WAS PERFORMED AND DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE REAGENT LOT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. 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. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I TSH REAGENT LOT 26158UD00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    MULTIPLE SAMPLES TESTED; REFER TO EVENT DESCRIPTION FOR DETAILS AND ALL AVAILABLE DEMOGRAPHIC INFORMATION. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED ALINITY I TSH RESULTS FOR TWO SAMPLES. THE FOLLOWING WAS PROVIDED: PATIENT 1 INITIAL RESULT 0.1 MIE/L, REPEATED WITH OTHER METHODS (ROCHE COBAS, BECKMAN ACCESS AND SIEMENS CENTAUR) 1.1 - 1.3 MIE/L. THE PATIENT WAS A WOMAN BORN IN (B)(6). PATIENT 2 (FROZEN SAMPLE, BEING EVALUATED FOR POTENTIAL SAMPLE INTERFERENCE) 0.1387 UIU/ML, REPEATED (DILUTED) 0.7215 UIU/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425990 ALINITY I TSH REAGENT KIT RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW A.I.D.D LONGFORD 07P4830 26158UD00 00380740131159

    Patients

    Seq Age Sex Outcome Treatment
    1 ALNTY I PROCESSING MODU, 03R65-01, AI01507| ALNTY I PROCESSING MODU, 03R65-01, AI01507