BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C CREATININE REAGENT KIT

    MDR report key: 20817152 · Received December 2, 2024

    Report

    Report Number
    3002809144-2024-00339
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    October 31, 2024
    Report Date
    January 17, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    CGX
    UDI-DI
    00380740173470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF TICKETS DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR ALINITY CREATININE LN 7P99 LOT 79666UN24. TRENDING REVIEW DETERMINED NO TRENDS FOR FALSELY ELEVATED RESULTS FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY CREATININE LN 7P99 LOT 79666UN24 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED CREATININE RESULT GENERATED ON THE ALINITY C PROCESSING MODULE ON A 74-YR OLD FEMALE PATIENT. RESULTS PROVIDED: (B)(6) 2024 SID (B)(6) = 333.77 UMOL/L, NEW SAMPLE ON ANOTHER ALINITY. (B)(6) 2024 SID (B)(6) = 59.04 UMOL/L (REFERENCE RANGE: 45.00-133.00 UMOL/L). RE-TESTED BOTH SAMPLES ON (B)(6) 2024 ON DIFFERENT ALINITY: (B)(6) 2024 SID (B)(6) = 352.38 UMOL/L. (B)(6) 2024 SID (B)(6) = 60.8 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED CREATININE RESULT GENERATED ON THE ALINITY C PROCESSING MODULE ON A 74-YR OLD FEMALE PATIENT. RESULTS PROVIDED: ON (B)(6) 2024, SID: (B)(6); 333.77 UMOL/L, NEW SAMPLE ON ANOTHER ALINITY ON (B)(6) 2024, SID: (B)(6); 59.04 UMOL/L (REFERENCE RANGE: 45.00-133.00 UMOL/L). RE-TESTED BOTH SAMPLES ON (B)(6) 2024 ON DIFFERENT ALINITY: ON (B)(6) 2024, SID: (B)(6); 352.38 UMOL/L, ON (B)(6) 2024, SID: (B)(6); 60.8 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327704 ALINITY C CREATININE REAGENT KIT ALKALINE PICRATE, COLORIMETRY, CREATININE CGX ABBOTT GMBH 79666UN24 00380740173470

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female ALNTY C PROCESSING MODU, 03R67-01, AC05399| ALNTY C PROCESSING MODU, 03R67-01, AC05399