BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1628664-2017-00233

    MDR report key: 6591425 · Received May 25, 2017

    Report

    Report Number
    1628664-2017-00233
    Event Type
    Malfunction
    Date Received
    May 25, 2017
    Report Date
    June 26, 2017
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED ABBOTT AND REQUESTED SERVICE TO ADDRESS THE ISSUE. THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED. MULTIPLE PARTS ASSOCIATED WITH THE CUVETTE WASHER WERE REPLACED. THE FSR DESIGNATED THE VACUUM PUMP, PART NUMBER 7-202560-01, AND THE CUVETTE WASH BELLOWS PUMP, PART NUMBER 7-202657-02 AS THE LIKELY CAUSE(S) FOR THE DISCREPANT RESULTS AND LEAKING CUVETTE WASH NOZZLES. A FOLLOW UP CALL WAS MADE TO THE CUSTOMER 3 DAYS AFTER THE INITIAL ISSUE WAS REPORTED. THERE WERE NO ADDITIONAL DISCREPANT RESULTS/LEAKING WASH NOZZLES OBSERVED. AN INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT RESULTS REPORTED ON (B)(4), NOR DID IT IDENTIFY ANY SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF HISTORICAL DATA FOR THE PARTS ASSOCIATED WITH THIS COMPLAINT REVEALED NO ADVERSE TREND ASSOCIATED WITH THE VACUUM PUMP OR THE CUVETTE WASH BELLOWS PUMP. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INFORMATION WITHIN THE COMPLAINT RECORD, A MALFUNCTION OF THE VACUUM PUMP, PART NUMBER 7-202560-01, AND THE CUVETTE WASH BELLOWS PUMP, PART NUMBER 7-202657-02. WAS IDENTIFIED. THE DEVICES FAILED TO MEET PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORM AS INTENDED AT THE CUSTOMER SITE. HOWEVER, A SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT IMPRECISION WAS OBSERVED ON THE ARCHITECT C16000 SYSTEM. AN INITIAL CALCIUM RESULT OF 5.7 MG/DL RETESTED AT 8.8 MG/DL. THE CUSTOMER NOTICED THAT THE CUVETTE WASHER NOZZLES WERE DRIPPING AND REQUESTED SERVICE. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Patients

    Seq Age Sex Outcome Treatment
    1