BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO XPRESS CHEMISTRY ANALYZER

    MDR report key: 16548227 · Received March 15, 2023

    Report

    Report Number
    2939693-2023-00001
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 9, 2023
    Report Date
    June 23, 2023
    Manufacturer
    ABAXIS, INC
    Product Code
    JJG
    UDI-DI
    EABA110000001
    PMA / PMN Number
    K934592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN AUTHORIZATION (RMA) WAS REQUESTED, AND THE INSTRUMENT AND ROTORS WERE RETURNED TO THE ABAXIS UNION CITY REPAIR CENTER FOR INVESTIGATION 30MAR2023. THIS UNIT HAS NO SERVICE HISTORY WITH ABAXIS. AFTER REVIEWING THE ANALYZER LOG FILE AND TESTING THE ANALYZER, THE ISSUE WAS DUPLICATED BY ABAXIS PRODUCT ASSURANCE (PA). LOG FILES INDICATED MULTIPLE TEMPERATURE WARNINGS THAT COULD CAUSE LOW AND HIGH POTASSIUM (K+) VALUES, AND THE DIGITAL ANALOG CONVERTER (DAC) AT 340NM WAS 112, SUGGESTING THE OPTIC ASSEMBLY WAS NOT WORKING AT ITS OPTIMUM. PA RECOMMENDED REPLACING HEATER PLATES, REPAIRING THE OPTICS ASSEMBLY, AND ENGINE PRINTED CIRCUIT BOARD (PCB). THE INVESTIGATION INCLUDED A REVIEW OF THE REAGENT LOTS, TRENDING, AND BATCH RECORDS AND DID NOT INDICATE ANY NON-CONFORMITIES. HEATER PLATES, OPTICS ASSEMBLY, DIGITAL VERSATILE DISC-READ ONLY MEMORY (DVD ROM), AND FLASH LAMP WERE REPLACED TO RESOLVE THE REPORTED PROBLEM. THE ANALYZER WAS CLEANED AND PASSED ALL REQUIRED TESTS. THE CUSTOMER HAS RECEIVED THE ANALYZER BACK WITH NO FURTHER CONCERNS. THE ROTORS WERE NOT RECEIVED BY PRODUCT ASSURANCE AND COULD NOT BE TESTED. A REVIEW OF THE BATCH RECORD FOR LOT 2417BB0 WAS COMPLETED AND CONFIRMED NO UNACCEPTABLE READINGS FOR POTASSIUM. THE LOT MET ALL RELEASE CRITERIA WITH NO DEVIATIONS DURING MANUFACTURING. A TOTAL OF 11,000 ROTORS FOR THIS LOT WERE MANUFACTURED AND SHIPPED. A REVIEW OF THE COMPLAINT DATA SHOWED THAT THERE WAS ONLY ONE (1) ROTOR FROM THIS LOT REPORTED FOR HIGH POTASSIUM FOR A COMPLAINT RATE OF 0.009%. THERE HAS BEEN NO OBSERVED TREND FOR HIGH POTASSIUM OVER THE LAST 12 MONTHS ENDING APRIL 2023. THERE HAS BEEN NO REPORTED PATIENT IMPACT CONTRIBUTING TO PATIENT INJURY OR HOSPITALIZATION. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THIS IS A REPORT FROM A LABORATORY HEALTH PROFESSIONAL FROM A LABORATORY INVOLVING THE PICCOLO XPRESS ANALYZER SERIAL NUMBER (B)(4) USING THE PICCOLO COMPREHENSIVE METABOLIC PANEL (CMP) LOT 2417BB0 (B)(6) 2023: ABAXIS TECHNICAL SUPPORT RECEIVED A CALL FROM A LABORATORY HEALTH PROFESSIONAL REPORTING A HIGH POTASSIUM (K+) RESULT ON THE PICCOLO XPRESS ANALYZER SERIAL NUMBER (B)(4) USING THE PICCOLO COMPREHENSIVE METABOLIC PANEL (CMP) LOT 2417BB0. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2023, 5:01 PM: WHOLE BLOOD WAS DRAWN INTO A LITHIUM HEPARIN TUBE FROM THE PATIENT AND ANALYZED USING THE PICCOLO XPRESS ANALYZER SERIAL NUMBER (B)(4) AND THE PICCOLO COMPREHENSIVE METABOLIC PANEL (CMP) LOT 2417BB0. RESULTS: POTASSIUM (K+) = 5.7 MMOL/L (REFERENCE RANGE: 3.5-5.1MMOL/L) BASED ON THESE RESULTS, THE PATIENT WAS TREATED WITH KAYEXALATE BASED ON THE PICCOLO XPRESS ANALYZER (B)(6) 2023 7:19 AM: A SERUM SAMPLE FROM THE INITIAL DRAW WAS SENT TO AN OUTSIDE LAB (LABCORP). RESULTS: POTASSIUM (K+) = 3.9 MMOL/L (REFERENCE RANGE: 3.5-5.1 MMOL/L) THE DOCTOR INSTRUCTED THE PATIENT TO STOP THE TREATMENT. THE PATIENT'S TREATMENT DID NOT CONTRIBUTE TO ANY FURTHER TREATMENT, ILLNESS, OR INJURY. (B)(6) 2023: A LABORATORY HEALTH PROFESSIONAL RAN QUALITY CONTROL ON THE PICCOLO XPRESS ANALYZER WITH PASSING RESULTS. THE LABORATORY PROFESSIONAL STATED ALTHOUGH THEY WERE NOT CONCERNED ABOUT THE PICCOLO XPRESS ANALYZER OR ASSOCIATED ROTORS, THEY WANTED TO REPORT THIS INCIDENT TO ABAXIS. THE CUSTOMER WILL BE SENDING THE REMAINING ROTORS FOR INVESTIGATION. THE CUSTOMER'S INSTRUMENT IS UNDER WARRANTY WITH NO HISTORY OF REPAIR COMPLETED BY ABAXIS SERVICE. ABAXIS TECHNICAL SUPPORT REQUESTED THE UNIT BE RETURNED FOR EVALUATION ALONG WITH SERVICE ARCHIVES AND QUALITY CONTROL DATA FOR FURTHER REVIEW. A FOLLOW-UP WILL BE PROVIDED ONCE THE INSTRUMENT IS RECEIVED BACK BY ABAXIS SERVICE, AND THE INVESTIGATION IS COMPLETED

    Description of Event or Problem · 0

    A LABORATORY HEALTHCARE PROFESSIONAL REPORTED UNEXPECTED HIGH POTASSIUM (K+) RESULTS. INVOLVING THE PICCOLO XPRESS ANALYZER SERIAL NUMBER (B)(4) USING THE PICCOLO COMPREHENSIVE METABOLIC PANEL (CMP) LOT 2417BB0. THE PATIENT WAS TREATED BASED ON THE RESULTS OF THE PICCOLO XPRESS CHEMISTRY ANALYZER RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114435 PICCOLO XPRESS CHEMISTRY ANALYZER PICCOLO ANALYZER JJG ABAXIS, INC 1100-0000 EABA110000001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown