BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 3053441 · Received April 11, 2013

    Report

    Report Number
    1628664-2013-00090
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    MZV
    PMA / PMN Number
    K980367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT POTASSIUM CONTROL VALUES AND PATIENT RESULTS DECREASED AFTER USING ICT CALIBRATOR LOT 12283UN12. SAMPLES RETESTED HIGHER WHEN TESTED WITH A DIFFERENT ICT CALIBRATOR LOT. TESTING WAS PERFORMED BY ABBOTT LABORATORIES USING ICT SERUM CALIBRATOR LOT 12283UN12 (RETURNS AND IN-HOUSE SAMPLES) AND 55593UN12 ( IN-HOUSE SAMPLES). ALL CONTROL RESULTS WERE WITHIN THE CONTROL RANGES AND MET ACCEPTANCE CRITERIA. REVIEW OF DATA FOR ICT SERUM CALIBRATOR LOT 12283UN12 DEMONSTRATES THAT IT WAS RELEASED WITHIN ITS FINAL RELEASE SPECIFICATIONS AND MET ALL OF ABBOTT'S ACCEPTANCE REQUIREMENTS PRIOR TO BEING RELEASED FOR DISTRIBUTION ON 10/05/2012. THE ICT SERUM CALIBRATOR PACKAGE INSERT, AND ICT (NA+, K+, CL) SAMPLE DILUENT PACKAGE INSERT WERE REVIEWED AND BOTH PROVIDE ADEQUATE LABELING FOR THE CUSTOMER'S ISSUE. A REVIEW OF CUSTOMER COMPLAINT TRENDING INDICATED NO ADVERSE OR NON-STATISTICAL TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. BASED ON THE DATA AVAILABLE AND THE RESULTS OF THIS EVALUATION, NO PRODUCT DEFICIENCY/ MALFUNCTION WAS IDENTIFIED WITH ICT SERUM CALIBRATOR LOT 12283UN12.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ARCHITECT POTASSIUM CONTROL VALUES AND PATIENT RESULTS DECREASED AFTER THEY STARTED USING ICT CALIBRATOR LOT 12283UN12 ON (B)(6) 2013. THE CUSTOMER STATED THAT SAMPLES RETESTED HIGHER WHEN A DIFFERENT CALIBRATOR LOT WAS USED. THE CALIBRATOR LOT IN QUESTION LED TO RESULTS OF HYPOKALEMIA. THE CUSTOMER STATED THAT THE PATIENTS WITH HYPOKALEMIA UNDERWENT A TREATMENT WITH POTASSIUM SALT THAT MAY NOT HAVE BEEN NECESSARY. THE CUSTOMER WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE TYPE OF TREATMENT, SPECIFIC RESULTS FOR THE PATIENTS TREATED, TOTAL NUMBER OF PATIENTS OR POTENTIAL HARM TO PATIENTS. NO PATIENT INJURY WAS REPORTED.THE CUSTOMER DID A STUDY BETWEEN ICT CALIBRATOR LOTS USING PREVIOUSLY TESTED PATIENT SAMPLES. FIVE EXAMPLES WERE PROVIDED. THE CUSTOMER'S NORMAL RANGE IS 3.50 - 5.10 MMOL/L.PATIENT ICT CAL LOT 12283UN12 ICT CAL LOT 29607UN121 3.20 3.59 2 3.48 3.813 3.29/3.27 3.604 4.00 4.335 3.32/3.36 3.67

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155926 ARCHITECT C4000 ANALYZER MZV ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ICT SERUM CALIBRATOR LIST 01E46-03 LOT 12283UN12| ICT SERUM CALIBRATOR LIST 01E46-03 LOT 12283UN12| ICT MODULE LIST 09D28-03 LOT UNKNOWN| ICT MODULE LIST 09D28-03 LOT UNKNOWN