BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C CALCIUM2

    MDR report key: 24524759 · Received March 5, 2026

    Report

    Report Number
    3005094123-2026-00108
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    February 12, 2026
    Report Date
    April 16, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CJY
    UDI-DI
    00380740156701
    PMA / PMN Number
    K244042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 04T87-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 04T87, WITH 510K/PMA/BLA NUMBER K244042. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C CALCIUM2 RESULTS FOR ONE SAMPLE DURING A RETROSPECTIVE REVIEW OF DATA. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE IS MMOL/L, CUSTOMER¿S ADJUSTED CALCIUM RANGE IS 2.08 TO 2.48 MMOL/L): (B)(6) 2026, SID (B)(6), (17-YEAR-OLD MALE PATIENT): E4·1 (B)(6) ¿ EXCEPTION CODE, E2·3 (B)(6) = 2.34, E4·1 (B)(6) = 4.34, E5·1 (B)(6) = 3.99, E3·1 (B)(6) = 2.28, E5·1 (B)(6) = 2.49 . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376479 ALINITY C CALCIUM2 AZO DYE, CALCIUM CJY ABBOTT IRELAND DIAGNOSTICS DIVISION 78404UD00 00380740156701

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male ALNTY C PROCESSING MODU, 03R67-01, (B)(6),| ALNTY C PROCESSING MODU, 03R67-01, (B)(6).