BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C MICROALBUMIN

    MDR report key: 21871297 · Received April 21, 2025

    Report

    Report Number
    3002809144-2025-00136
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    April 1, 2025
    Report Date
    May 22, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    JIQ
    UDI-DI
    00380740190781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF COMPLAINTS FOR THE ALINITY C MICROALBUMIN ASSAY DETERMINED THAT THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. FILE SAMPLE ANALYSIS WAS NOT PERFORMED AS THE ISSUE WAS FOUND TO BE THE URINE MICROALBUMIN ASSAY WAS CONFIGURED INCORRECTLY ON THE ALINITY C PROCESSING MODULE THE UNIT SHOULD BE CONFIGURED ON THE ANALYZER TO BE UG/ML OR MG/L, NOT MG/DL. THE PATIENT SAMPLES RESULTS WERE RECALCULATED AFTER CORRECTING THE ASSAY PARAMETERS AND RESULTS WERE AS EXPECTED WITH THE UNITS OF MEASUREMENT. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. SECTION A1 PATIENT IDENTIFIER SIDS: (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE URINE MICROALBUMIN ASSAY WAS CONFIGURED INCORRECTLY ON THE ALINITY C PROCESSING MODULE BY ABBOTT RESULTING IN FIVE PATIENT SAMPLES 10X HIGHER THAN PREVIOUS HISTORY. EXAMPLE RESULTS PROVIDED: SID (B)(6): RAW RESULT 0.769; RESULT REPORTED 7.6912 MG/DL. SID (B)(6): RAW RESULT: 17.618; RESULT REPORTED:176.1848 MG/DL. THE UOM SHOULD BE CONFIGURED ON THE ANALYZER TO BE UG/ML OR MG/L, NOT MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE URINE MICROALBUMIN ASSAY WAS CONFIGURED INCORRECTLY ON THE ALINITY C PROCESSING MODULE BY ABBOTT RESULTING IN FIVE PATIENT SAMPLES 10X HIGHER THAN PREVIOUS HISTORY. EXAMPLE RESULTS PROVIDED: SID (B)(6): RAW RESULT 0.769; RESULT REPORTED 7.6912 MG/DL SID (B)(6): RAW RESULT: 17.618; RESULT REPORTED:176.1848 MG/DL THE UOM SHOULD BE CONFIGURED ON THE ANALYZER TO BE UG/ML OR MG/L, NOT MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338652 ALINITY C MICROALBUMIN TURBIDIMETRIC METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) JIQ ABBOTT GMBH 66362UD00 00380740190781

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY C PROCESSING MODU, 03R67-01, (B)(6)| ALNTY C PROCESSING MODU, 03R67-01, (B)(6)