BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO XPRESS CHEMISTRY ANALYZER

    MDR report key: 11642447 · Received April 9, 2021

    Report

    Report Number
    2939693-2021-00002
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 12, 2021
    Report Date
    August 6, 2021
    Manufacturer
    ABAXIS, INC.
    Product Code
    JJG
    UDI-DI
    EABA110000001
    PMA / PMN Number
    K934592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF A THREE-YEAR RETROSPECTIVE REVIEW OF COMPLAINTS FOR THE QUALITY IMPROVEMENT PROCESS, CALLS WERE IDENTIFIED IN WHICH THE CUSTOMER EXPERIENCED BURNING ODOR AND/OR SMOKE. THERE WERE NO INJURIES RELATED TO THE CUSTOMER COMPLAINTS RECEIVED, BASED ON THE POTENTIAL OF BURNING SMELL/SMOKE TO LEAD TO A POTENTIAL INJURY. BASED ON MDR REGULATIONS, ABAXIS REPORTED THESE EVENTS DUE TO: 1) THE LIKELIHOOD OF THIS MALFUNCTION TO LEAD TO AN ADVERSE EVENT, ALTHOUGH THERE WAS NO EVIDENCE OR REPORTS OF ASSOCIATED ADVERSE EVENTS. 2) MINIMAL DETAILED DOCUMENTATION RELATED TO THE LIKELIHOOD AND CAUSE OF BURNING ODOR AND SMOKE. AS PART OF AN INVESTIGATION REGARDING THE OVERALL REPORTED MALFUNCTION OF A BURNING ODOR AND/OR SMOKING, RISK ASSESSMENT, AND MAUDE DATABASE SEARCH, ZOETIS HAS CONCLUDED THAT THE BURNING ODOR/SMOKE OVERHEATING COMPLAINTS ARE A LOW INJURY RISK FOR THE USER OR PATIENT. THE IDENTIFIED MALFUNCTIONS HAVE NOT CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY NOR DOES THE DATA SUGGEST THAT THE DEVICE OR A SIMILAR DEVICE MARKETED WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO REOCCUR. ZOETIS WILL CONTINUE TO MONITOR COMPLAINTS FOR BURNING ODOR/SMOKING/OVERHEATING TO DETERMINE IF ANY NEW INFORMATION IS OBTAINED AND ANY CHANGE TO THE RISKS FOR PATIENTS OR USERS OF THE PICCOLO XPRESS ANALYZER. IF NEW INFORMATION IS OBTAINED, NEW CAUSES WHERE RISK HAS NOT BEEN EVALUATED, POTENTIAL OF SERIOUS INJURY REPORTED OR IDENTIFIED, THE SITE WILL FOLLOW THE REQUIRED PROCESS FOR MDR REPORTING AND TIMELINESS.

    Additional Manufacturer Narrative · 0

    UPON EVALUATION OF THE DEVICE, THE REPORTED PROBLEM OF BURNING SMELL WAS CONFIRMED. THE BALL LOCK PIN BEARINGS WERE FOUND TO BE DIRTY AND STICKING DUE TO BLOOD SPLATTER. BLOOD SPLATTER WAS ALSO FOUND ON TOP OF SPINDLE AND THROUGHOUT THE CHAMBER. THE BALL LOCK PIN COULD NOT HOLD THE ROTOR CORRECTLY, CAUSING FRICTION AND A BURNING ODOR ONCE THE SPINDLE STARTED TO SPIN. THE BALL LOCK PIN ASSEMBLY AND SPINDLE MOTOR WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE DEVICE WAS CLEANED, PASSED ALL REQUIRED TESTING, AND WAS SENT BACK TO THE CUSTOMER SITE. AS PART OF AN INVESTIGATION REGARDING THE OVERALL REPORTED MALFUNCTION OF A BURNING ODOR AND/OR SMOKING, RISK ASSESSMENT, AND MAUDE DATABASE SEARCH, ZOETIS HAS CONCLUDED THAT THE BURNING ODOR/SMOKE OVERHEATING COMPLAINTS ARE A LOW INJURY RISK FOR THE USER OR PATIENT. THE IDENTIED MALFUNCTIONS HAVE NOT CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY NOR DOES THE DATA SUGGEST THAT THE DEVICE OR A SIMILAR DEVICE MARKETED WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE RECUR.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2021, ABAXIS RECEIVED A CALL FROM CUSTOMER LAB REPORTING AN ISSUE WITH ANALYZER SN: (B)(4) STATING THAT THE DEVICE DISPLAYED A 4057 ERROR CODE AND WAS EMITTING A BURNING SMELL THAT SMELLED LIKE PLASTIC OR ELECTRICAL. NO FIRE OR INJURY WAS REPORTED. THE CUSTOMER WAS INSTRUCTED BY ABAXIS TECHNICAL SUPPORT TO IMMEDIATELY POWER OFF THE DEVICE. EVALUATION OF THE DEVICE IS ANTICIPATED AND PENDING CUSTOMER SHIPMENT. FURTHER INFORMATION WILL BE PROVIDED IN A FOLLOW UP REPORT WHEN RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED A 4057 ERROR CODE AND WAS EMITTING A BURNING SMELL. NO FIRE OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537648 PICCOLO XPRESS CHEMISTRY ANALYZER PICCOLO ANALYZER JJG ABAXIS, INC. 1100-0000 EABA110000001

    Patients

    Seq Age Sex Outcome Treatment
    1