BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1628664-2017-00362

    MDR report key: 6902403 · Received September 28, 2017

    Report

    Report Number
    1628664-2017-00362
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    August 31, 2017
    Report Date
    November 9, 2017
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THE WASTE AROUND THE TUBING NEAR THE WASTE PUMP APPEARED PARTIALLY BLOCKED AND WAS CLEANED. THE FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO THE SITE AND REPLACED, CALIBRATED, AND INSPECTED MULTIPLE PARTS PROACTIVELY. NO PARTS WERE IDENTIFIED AS LIKELY CAUSES OF THE OBSERVED ISSUE. AN INTERNAL DECONTAMINATION PROCEDURE WAS COMPLETED DUE TO RESULTS OF WATER SAMPLES COLLECTED FROM THE LABORATORY, HOWEVER THE SPECIFIC WATER SAMPLE TESTS AND RESULTS WERE NOT PROVIDED. THE ANALYZER WATER BATH OR OTHER INTERNAL COMPONENTS COULD NOT BE ELIMINATED AS CONTRIBUTING TO THE ISSUE DUE TO THE IDENTIFIED WATER CONTAMINATION. PARTS WERE INSPECTED AND REPLACED, INCLUDING TUBINGS [C8000 SAMPLE PROBE TUBING PART 01G48-04, TBG, ALK NOZZLE B TO VACUUM MAN PART 7-203105-01], SYRINGES [SEAL, WATER LINE SYRINGE PART 2-89347-02], NOZZLES [NOZZLE PAIRS 2-3,WASH SOLUTION PART 2-89270-02, NOZZLE, DRY PART 2-89271-0], CUVETTE DRYING TIP [PART 09D51-02 ], AND PROBE [C16 RGT PR(L)ROHS 09D48-03] BECAUSE THE PARTS COULD NOT BE RULED OUT AS CONTRIBUTORS THE ISSUE OR AS BEING CONTAMINATED. THE ANALYZER WAS CALIBRATED AND RETURNED TO NORMAL OPERATION. EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, INSTRUMENT LOG REVIEW, AND LABELING REVIEW. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE ARCHITECT C1600416 SERVICE HISTORY CONFIRMED PROCEDURE 2181 INTERNAL DECONTAMINATION WAS COMPLETED ON 10/04/2017 DUE TO THE RESULTS OF THE WATER SAMPLES COLLECTED FROM THE LAB. ADDITIONAL LOG REVIEW DID NOT IDENTIFY ANY OTHER ISSUES THAT CONTRIBUTED TO THE CUSTOMER ISSUE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS EVALUATION, NO SYSTEMIC ISSUE WAS IDENTIFIED AND NO PRODUCT DEFICIENCY WAS FOUND.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED DISCREPANT CALCIUM RESULTS WHILE USING THE ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (MMOL/L). (B)(4) INITIAL 2.13, REPEAT 0.7. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Patients

    Seq Age Sex Outcome Treatment
    1