BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY MAGNESIUM

    MDR report key: 2480291 · Received March 6, 2012

    Report

    Report Number
    1628664-2012-00116
    Event Type
    Malfunction
    Date Received
    March 6, 2012
    Date of Event
    February 16, 2012
    Report Date
    February 16, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JGJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) INDICATED THAT THE PATIENT WAS INJECTED WITH NAPRESOL (HYDRALAZINE, A DRUG TO LOWER HIGH BLOOD PRESSURE) BEFORE TESTED FOR THE MAGNESIUM. THE INFORMATION ALSO INDICATED (PER THE CUSTOMER'S CLINICAL CHEMIST) THAT NAPRESOL COULD INTERFERE WITH THE MAGNESIUM AND CAUSE LOW MAGNESIUM RESULTS.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION WAS CONDUCTED IN ORDER TO INVESTIGATE THIS ISSUE. (B)(4). BASED ON THE RESULTS OF THIS EVALUATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED RELATED TO THE ALLEGED MALFUNCTION REPORTED BY THE CUSTOMER. HOWEVER; THE CUSTOMER WAS REFERRED TO BOTH THE CLINICAL CHEMISTRY MAGNESIUM PACKAGE INSERT AND THE ARCHITECT SYSTEMS OPERATIONS MANUAL WHICH ARE AVAILABLE AS A REFERENCE. THE OPERATIONAL PRECAUTIONS AND LIMITATIONS STATES THAT ASSAY RESULTS MUST BE USED WITH OTHER CLINICAL DATA, FOR EXAMPLE, SYMPTOMS, OTHER TEST RESULTS, PATIENT HISTORY, CLINICAL IMPRESSIONS, INFORMATION AVAILABLE FROM CLINICAL EVALUATION, AND OTHER DIAGNOSTIC PROCEDURES. ALL DATA MUST BE CONSIDERED FOR PATIENT CARE MANAGEMENT. IF ASSAY RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. THE ARCHITECT SYSTEM HAS BEEN VALIDATED FOR ITS INTENDED USE. HOWEVER, ERRORS CAN OCCUR DUE TO POTENTIAL OPERATOR ERRORS AND ARCHITECT SYSTEM TECHNOLOGY LIMITATIONS. THE ASSAY PACKAGE INSERT PROVIDED INSTRUCTION FOR SAMPLE COLLECTION AND PROCESSING ALONG WITH PREVENTIVE AND CORRECTIVE ACTIONS FOR SUCH AN ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ONE PATIENT PRESENTED WITH ECLAMPSIA WAS INJECTED WITH MAGNESIUM. A SAMPLE FROM THIS PATIENT WAS THEN TESTED FOR THE CLINICAL CHEMISTRY MAGNESIUM AND A LOWER THAN EXPECTED RESULT OF <0.27 MMOL/L (0.54 MEQ/L) WAS GENERATED TWICE AND THE SAME RESULT WAS ALSO GENERATED FROM THIS SAMPLE WHEN TESTED ON A DIFFERENT ANALYZER. THIS SAMPLE WAS THEN TESTED USING A NEW REAGENT LOT AND A RESULT OF 1.83 MMOL/L (3.66 MEQ/L) WAS OBTAINED. A NEW SAMPLE FROM THE SAME PATIENT WAS TESTED THE NEXT DAY PER THE DOCTOR'S REQUEST AND A RESULT OF 2.02 MMOL/L (4.04 MEQ/L) WAS GENERATED USING THE ORIGINAL REAGENT LOT AND A RESULT OF 2.07 MMOL/L (4.14 MEQ/L) WAS OBTAINED AFTER TESTING THE SAMPLE WITH THE NEW REAGENT LOT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY MAGNESIUM JGJ ABBOTT MANUFACTURING INC 20463UN11

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C16000 SYSTEM| ARCHITECT C16000 SYSTEM