BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1628664-2017-00061

    MDR report key: 6387462 · Received March 8, 2017

    Report

    Report Number
    1628664-2017-00061
    Event Type
    Malfunction
    Date Received
    March 8, 2017
    Date of Event
    February 3, 2017
    Report Date
    April 5, 2017
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF: THE COMPLAINT TEXT, SERVICE HISTORY, TREND REPORTS, COMPLAINT SEARCHES, AND PRODUCT LABELING. THE CUSTOMER OBSERVED ERRATIC RESULTS ON SEVERAL TESTS FOR MULTIPLE PATIENT SAMPLES ON ARCHITECT C1600986. UPON A SITE VISIT, THE FIELD SERVICE ENGINEER (FSE) FOUND THE HIGH CONCENTRATION PERISTALTIC PUMP TUBING FOR THE 1B PROBE LEAKING AND THE CUVETTES WERE OVERFLOWING. THE FSE PERFORMED TROUBLESHOOTING: CLEANING THE LOW CONCENTRATION WASTE MANIFOLD AND TANK, REPLACING THE CUVETTE DRY TIPS, AND REPLACING THE PERISTALTIC HEAD TUBING (ROHS) (PART NUMBER 7-202464-01). A REVIEW OF THE ARCHITECT C1600986 SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS ON OR AROUND THE DATE OF THE COMPLAINT. THERE HAVE BEEN NO SUBSEQUENT CONTACTS FROM THE CUSTOMER REGARDING ERRATIC OR DISCREPANT RESULTS SINCE THE PERISTALTIC HEAD TUBING (ROHS) WAS REPLACED. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES ADEQUATE INFORMATION FOR TROUBLESHOOTING ERRATIC/DISCREPANT RESULTS. THE ARCHITECT C16000 SYSTEM SERVICE AND SUPPORT MANUAL PROVIDES INSTRUCTIONS FOR THE REMOVAL, REPLACEMENT AND VERIFICATION OF THE PERISTALTIC HEAD TUBING (ROHS). A SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED NO ADVERSE TREND OF PERISTALTIC HEAD TUBING (ROHS) IN THE PAST 12 MONTHS. A REVIEW OF THE ARCHITECT C16000 TRACKING AND TRENDING REVEALED NO SYSTEMIC ISSUES OR TRENDS ASSOCIATED WITH ERRATIC RESULTS. A MALFUNCTION WAS IDENTIFIED FOR THE PERISTALTIC HEAD TUBING (ROHS) (PART NUMBER 7-202464-01) AS THE DEVICE FAILED TO MEET PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORM AS INTENDED AT THE CUSTOMER SITE. NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE PART OR THE ARCHITECT C16000.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE ARCHITECT ANALYZER GENERATED FALSELY ELEVATED CREATININE RESULTS ON 2 PATIENTS. THE RESULTS PROVIDED WERE: (B)(6) = CREATININE 348 / 50 UMOL/L; (B)(6) = CREATININE 323 / 72UMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Patients

    Seq Age Sex Outcome Treatment
    1