BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCIUM

    MDR report key: 14361121 · Received May 11, 2022

    Report

    Report Number
    3002809144-2022-00171
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    April 18, 2022
    Report Date
    June 16, 2022
    Manufacturer
    ABBOTT GMBH
    Product Code
    CJY
    UDI-DI
    00380740161507
    PMA / PMN Number
    K062855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. PATIENT IDENTIFIER FOR THE SECOND SAMPLE IS (B)(6).

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED CALCIUM RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT NUMBER 90112UN21 AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE CALCIUM ASSAY FOR LOT 90112UN21 WAS IDENTIFIED. SECTION A: PATIENT IDENTIFIER FOR THE SECOND SAMPLE IS (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM RESULTS ON THE ARCHITECT C16000 PROCESSING MODULE. TWO EXAMPLES WERE PROVIDED. SID (B)(4) 15.6 MG/DL (C16000), 9.63 MG/DL (C8000), SID (B)(4) 16.3 MG/DL (C16000), 9.47 MG/DL (C8000), NORMAL RANGE: 8.4 TO 10.2 MG/DL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM RESULTS ON THE ARCHITECT C16000 PROCESSING MODULE. TWO EXAMPLES WERE PROVIDED. SID (B)(6): 15.6 MG/DL (C16000), 9.63 MG/DL (C8000). SID (B)(6): 16.3 MG/DL (C16000), 9.47 MG/DL (C8000). NORMAL RANGE: 8.4 TO 10.2 MG/DL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600654 CALCIUM AZO DYE, CALCIUM CJY ABBOTT GMBH 3L79-32 90112UN21 00380740161507

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC C16K PRC MOD, 03L77-01, C1600177| ARC C16K PRC MOD, 03L77-01, C1600177