BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C CARBON DIOXIDE REAGENT KIT

    MDR report key: 12940165 · Received December 6, 2021

    Report

    Report Number
    3002809144-2021-00687
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    November 1, 2021
    Report Date
    January 13, 2022
    Manufacturer
    ABBOTT GMBH
    Product Code
    KHS
    UDI-DI
    00380740121594
    PMA / PMN Number
    K060295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP SUBMISSION BEING SEND TO CROSS REFERENCE MDR 3016438761-2022-00023-00 FOR LIKELY CAUSE CHANGED ON (B)(6) 2021; CARBON DIOXIDE REAGENT, LIST NUMBER 07P72-20 TO ALINITY C PROCESSING MODULE, LIST 03R67-01.

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, PATIENT IDENTIFIER = SID= SID (B)(6) AND (B)(6). PATIENT INFORMATION: NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. THE COMPLAINT EVALUATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW FOR ALINITY CARBON DIOXIDE REAGENT LOT NUMBER 59601UQ04. THE TICKET SEARCH DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. TRENDING REVIEW DETERMINED NO ADVERSE TREND FOR THE ISSUE FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY CARBON DIOXIDE, LOT 59601UQ04 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED CARBON DIOXIDE RESULTS ON ALINITY C PROCESSING MODULE FOR MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 SID 466434 CO2=32 MMOL/L /REPEATED=30 MMOL/L. ON (B)(6) 2021 SID 479538 CO2=37 MMOL/L/REPEATED=33 MMOL/L. LABORATORY NORMAL REFERENCE RANGE: 1-4 YEARS= 14 TO 24 MMOL/L; 5-17 YEARS=17 TO 28 MMOL/L; 18-60 YEARS=23 TO 29 MMOL/L; >60 YEARS= 23 TO 31 MMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834451 ALINITY C CARBON DIOXIDE REAGENT KIT ENZYMATIC, CARBON-DIOXIDE KHS ABBOTT GMBH 07P7220 59601UQ04 00380740121594

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY C PROCESSING MODU, 03R67-01, AC01935| ALNTY C PROCESSING MODU, 03R67-01, AC01935