BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C CALCIUM2

    MDR report key: 24169048 · Received January 23, 2026

    Report

    Report Number
    3005094123-2026-00035
    Event Type
    Malfunction
    Date Received
    January 23, 2026
    Date of Event
    January 14, 2026
    Report Date
    January 30, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CJY
    UDI-DI
    00380740156695
    PMA / PMN Number
    K244042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM CALCIUM2 REAGENT, LIST 04T87-20 (ABBOTT IRELAND DIAGNOSTICS DIVISION, LONGFORD, IRELAND) TO THE ALINITY C PROCESSING MODULE, LIST 03R67-01 (ABBOTT LABORATORIES, IRVING, TEXAS, USA). MDR NUMBER 3016438761-2026-00054 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED CALCIUM2 RESULT WAS GENERATED BY THE ALINITY C PROCESSING MODULE FOR A 76-YEAR-OLD MALE PATIENT. THE FOLLOWING DATA WERE PROVIDED: CUSTOMER¿S REFERENCE RANGE: 2.1 TO 2.55 MMOL/L. SID (B)(6): ON (B)(6) 2026 INITIAL RESULT (B)(6) = 2.0 MMOL/L. REPEAT RESULTS ((B)(6) = 5.0 MMOL/L, 1.9 MMO/L, 2.0 MMOL/L. THE CUSTOMER REPORTED THE RESULT OF 2.0 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED CALCIUM2 RESULT WAS GENERATED BY THE ALINITY C PROCESSING MODULE FOR A 76-YEAR-OLD MALE PATIENT. THE FOLLOWING DATA WERE PROVIDED: CUSTOMER¿S REFERENCE RANGE: 2.1 TO 2.55 MMOL/L SID (B)(6): (B)(6) 2026 INITIAL RESULT (B)(6) = 2.0 MMOL/L REPEAT RESULTS (B)(6) = 5.0 MMOL/L, 1.9 MMO/L, 2.0 MMOL/L THE CUSTOMER REPORTED THE RESULT OF 2.0 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230093 ALINITY C CALCIUM2 AZO DYE, CALCIUM CJY ABBOTT IRELAND DIAGNOSTICS DIVISION 77211UD00 00380740156695

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male ALNTY C PROCESSING MODU, 03R67-01, (B)(6)| ALNTY C PROCESSING MODU, 03R67-01, (B)(6)