BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCIUM

    MDR report key: 10476090 · Received September 1, 2020

    Report

    Report Number
    3016438761-2020-00193
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Date of Event
    August 12, 2020
    Report Date
    September 14, 2020
    Manufacturer
    ABBOTT LABORATORIES (IRVING IA/CC)
    Product Code
    CJY
    UDI-DI
    00380740005924
    PMA / PMN Number
    K062855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO SECTION D. SUSPECT MEDICAL DEVICE: 1. BRAND NAME FROM ARCHITECT C16000 SYSTEM TO CALCIUM 2. COMMON DEVICE NAME FROM AUTOMATED CHEMISTRY ANALYZER TO CALCIUM; PRODUCT CODE FROM JJE TO CJY 4. CATALOG # FROM 03L77-01 TO 03L79-21; SERIAL # FROM C1601877 TO BLANK; LOT # FROM BLANK TO 84863UN19; UDI FROM (B)(4). CONCOMITANT FROM CALCIUM; LN 03L79-21; LOT # 84863UN19 TO ARCHITECT C16000 SYSTEM; LN 03L77-01; SERIAL # (B)(6) SECTION G 5. FROM PMA/510(K) # EXEMPT TO K062855 A REVIEW OF TICKETS DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR REAGENT LOT 84863UN19. TRENDING REVIEW DETERMINED NO TRENDS FOR FALSELY ELEVATED RESULTS FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE ISSUE APPEARS TO BE SPECIFIC TO THE REAGENT WEDGE. EXCESSIVE BUBBLES WERE FOUND INSIDE THE REAGENT BOTTLE, REAGENT PROBE WAS BENT, AND QUALITY CONTROL (QC) RESULTS WERE REPORTED TO BE WITHIN EXPECTED RANGES. 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 PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT CALCIUM REAGENT, LOT 84863UN19.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSELY DEPRESSED CALCIUM (CA) RESULT ON ONE PATIENT GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: ON (B)(6) 2020. SID: (B)(6)= 3.7MG/DL / REPEATED ON DIFFERENT ANALYZER =8.5 (NORMAL RANGE 8.5 -10.5MG/DL). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941788 CALCIUM CALCIUM CJY ABBOTT LABORATORIES (IRVING IA/CC) 3L77-01 84863UN19 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C16000 SYSTEM, LN 03L77-01,| CALCIUM, LN 03L79-21, LOT # 84863UN19| SERIAL # (B)(6)