BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C MAGNESIUM

    MDR report key: 25281118 · Received May 26, 2026

    Report

    Report Number
    3005094123-2026-00248
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    March 21, 2026
    Report Date
    May 26, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    JGJ
    UDI-DI
    00380740176525
    PMA / PMN Number
    K181748
    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

    SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 77635UD00; HOWEVER, NO TRENDS WERE IDENTIFIED FOR THE MAGNESIUM ASSAY (LIST NUMBER 08P19). A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS WITH LOT NUMBER 77635UD00 AND THE COMPLAINT ISSUE. THE HISTORICAL PERFORMANCE OF REAGENT LOT 77635UD00 WAS EVALUATED USING WORLD-WIDE DATA. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR THE COMPLAINT LOT IS WITHIN THE ESTABLISHED CONTROL LIMITS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE MAGNESIUM REAGENT, LOT NUMBER 77635UD00.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED BY THE ALINITY C PROCESSING MODULE FOR MULTIPLE PATIENT SAMPLES. THESE RESULTS HAD BEEN RELEASED FROM THE LABORATORY. UPON REPEAT TESTING, NORMAL RESULTS WERE OBTAINED, AND THE REPORTS HAVE SINCE BEEN CORRECTED. IT WAS NOTED THAT THE QUALITY CONTROLS WERE WITHIN RANGE PRIOR TESTING PATIENTS; HOWEVER, THEY WERE OUT OF RANGE AFTER THE DISCREPANT RESULTS WERE GENERATED. THE FOLLOWING DATA WAS PROVIDED: NORMAL RANGE 1.6 - 2.6 MG/DL. (B)(6) 2026 16:55, (B)(6) > 9.5 MG/DL, REPEAT RESULT = (DATA UNAVAILABLE AT THIS TIME). (B)(6) 2026 17:15, (B)(6) > 9.5 MG/DL, REPEAT RESULT = 2.0 MG/DL ((B)(6) @ 3/21 19:32). (B)(6) 2026 17:18, (B)(6) > 9.5 MG/DL, REPEAT RESULT = L 2.3 MG/DL ((B)(6) @ 3/21 20:13). (B)(6) 2026 17:19, (B)(6) > 9.5 MG/DL, REPEAT RESULT = 2.0 MG/DL ((B)(6) @ 3/21 19:59). (B)(6) 2026 17:27, (B)(6) > 9.5 MG/DL, REPEAT RESULT = 1.8 MG/DL ((B)(6) @ 3/21 18:52). (B)(6) 2026 17:53, (B)(6) > 9.5 MG/DL, REPEAT RESULT = 2.0 MG/DL ((B)(6) @ 3/21 20:15) . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439384 ALINITY C MAGNESIUM PHOTOMETRIC METHOD, MAGNESIUM JGJ ABBOTT IRELAND DIAGNOSTICS DIVISION 77635UD00 00380740176525

    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).