BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCIUM

    MDR report key: 14104255 · Received April 13, 2022

    Report

    Report Number
    3002809144-2022-00129
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    March 25, 2022
    Report Date
    May 19, 2022
    Manufacturer
    ABBOTT GMBH
    Product Code
    CJY
    UDI-DI
    00380740161491
    PMA / PMN Number
    K062855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    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. PATIENT IDENTIFIER = (B)(6). NO FURTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE COMPLAINT ISSUE INCLUDED REVIEW OF THE COMPLAINT DETAILS, COMPLAINT ACTIVITY, TRENDING REPORTS, DEVICE HISTORY RECORDS AND LABELING. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE CUSTOMER DETERMINED THERE WERE BUBBLES ON THE SURFACE OF THE SPECIMEN, INDICATING A POSSIBLE PRE-ANALYTICAL CONDITION MAY HAVE CAUSED THE INITIAL LOW RESULT. REVIEW OF COMPLAINT ACTIVITY AND TRENDING DATA DID NOT IDENTIFY ANY ISSUES OR TRENDS. REVIEW OF DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE COMPLAINT ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WERE IDENTIFIED FOR THE ARCHITECT CALCIUM ASSAY.

    Description of Event or Problem · 0

    THE CUSTOMER OBTAINED A FALSELY DEPRESSED ARCHITECT CALCIUM RESULT. THE CUSTOMER USES A NORMAL RANGE OF 8 TO 10 MG/DL. ON (B)(6) 2022 SAMPLE ID (B)(6) GENERATED AN INITIAL RESULT OF 3.4 MG/DL, WHICH WAS INCONSISTENT WITH THE PATIENT'S PREVIOUS RESULT OF (B)(6) MG/DL. THE SAMPLE WAS REPEAT TWICE AND GENERATED (B)(6) AND (B)(6) MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBTAINED A FALSELY DEPRESSED ARCHITECT CALCIUM RESULT. THE CUSTOMER USES A NORMAL RANGE OF 8 TO 10 MG/DL. ON (B)(6) 2022 SAMPLE ID (B)(6) GENERATED AN INITIAL RESULT OF 3.4 MG/DL, WHICH WAS INCONSISTENT WITH THE PATIENT'S PREVIOUS RESULT OF 9.5 MG/DL. THE SAMPLE WAS REPEAT TWICE AND GENERATED 9.9 AND 9.9 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2564625 CALCIUM AZO DYE, CALCIUM CJY ABBOTT GMBH 3L79-22 61446UN21 00380740161491

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC C8 PROC MOD, 01G06-11, C804394| ARC C8 PROC MOD, 01G06-11, C804394