BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO COMPREHENSIVE METABOLIC PANEL

    MDR report key: 14686943 · Received June 14, 2022

    Report

    Report Number
    2939693-2022-00003
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    May 16, 2022
    Report Date
    June 14, 2022
    Manufacturer
    ABAXIS, INC
    Product Code
    JGS
    UDI-DI
    EABA40000281
    PMA / PMN Number
    K993211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A REPORT FROM A LABORATORY HEALTH PROFESSIONAL FROM A CLINIC INVOLVING THE COMPREHENSIVE METABOLIC PANEL (PART NUMBER 400-028) LOT 2066AB0, RAN ON THE PICCOLO XPRESS CHEMISTRY ANALYZER RECEIVED BY ABAXIS TECHNICAL SUPPORT. THE LABORATORY HEALTH PROFESSIONAL REPORTED UNEXPECTED HIGH SODIUM (NA+) TEST RESULTS. (B)(6) 2022: ABAXIS TECHNICAL SUPPORT RECEIVED A CALL FROM A HEALTH PROFESSIONAL REPORTING HIGH SODIUM (NA+) RESULTS USING THE COMPREHENSIVE METABOLIC PANEL (CMP) (PART NUMBER 400-028) LOT 2066AB0 RAN ON (B)(6) 2022. THE CLINIC RERAN THE PATIENT SAMPLES ON THE METYLYE 8, LOT# 1522AB8, THE SAME DAY. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2022 (UNKNOWN TIME)-WHOLE BLOOD WAS ANALYZED WITH THE PICCOLO EXPRESS ANALYZER USING CMP LOT # 2066AB0 NA+ = 148 (135-145) MMOL/L. (B)(6) 2022 (UNKNOWN TIME)- A SECOND RUN USING THE SAME WHOLE BLOOD SAMPLE WAS RUN ON THE PICCOLO EXPRESS ANALYZER USING METLYTE 8 PANEL LOT# 1522AB8, NA+=144 (135-145) MMOL/L. (B)(6) 2022: THE CLINIC CALLED ABAXIS TECHNICAL SUPPORT TO REITERATE THEIR CONCERN WITH LOT CMP (B)(4), LOT 2066AB0 AND PERFORMED A COMPARISON OF LOT 2066AB0 AGAINST ANOTHER CMP LOT. WHOLE BLOOD WAS ANALYZED WITH THE PICCOLO EXPRESS CHEMISTRY ANALYZER ON THREE SEPARATE PATIENTS, THIS DATA WAS NOT USED FOR DIAGNOSIS OR TREATMENT. PER INFORMATION PROVIDED BY THE CLINIC, THE PATIENT WAS NOT EXPERIENCING ANY CLINICAL SIGNS OR SYMPTOMS. THE PATIENT WAS DIAGNOSED WITH HYPERNATREMIA AND TREATED BASED ON THE PICCOLO EXPRESS CHEMISTRY ANALYZER RESULTS. IT COULD NOT BE CONFIRMED WHETHER THE PATIENT WAS TREATED AFTER THE CMP RESULTS OR METLYTE 8 PANEL RESULTS RAN ON THE (B)(6) 2022. TREATMENT CONSISTED OF GATORADE AND WATER PRIOR TO THE PATIENT BEING RELEASED. AS REPORTED, THE THIS PICCOLO EXPRESS CHEMISTRY ANALYZER -RESULTS FROM CMP PANEL LOT #2066AB0 DID NOT IMPACT THE PATIENT OR CONTRIBUTE TO FURTHER INJURY OR ILLNESS. THE REPORTER WAS CONCERNED ABOUT THE RESULTS OBTAINED FROM CMP (B)(4), LOT # 2066AB0. A RETURN MERCHANDISE AUTHORIZATION (RMA) WAS INITIATED FOR FURTHER INVESTIGATION ON THE UNUSED PANELS FROM LOT # 2066AB0 AND A REPLACEMENT LOT WAS SENT TO THE CLINIC. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    8AUG2022: MANUFACTURING SITE INVESTIGATION RESPONSE (CIR 22_0064H): ZOETIS PRODUCT ASSURANCE TESTED THE RETURNED ROTORS AND COULD NOT CONFIRM HIGH SODIUM ON LOT# 2066AB0. TECHNICAL SERVICE SUPPORT FOLLOWED UP WITH THE CLINIC TO REPORT THE INVESTIGATION FINDINGS. THE CLINIC INDICATED THAT THEY WERE NO LONGER EXPERIENCING ANY FURTHER ISSUES WITH THE SODIUM RESULTS. A REVIEW OF THE BATCH RECORD FOR LOT # 2066AB0 CONFIRMED THERE WERE NO UNACCEPTABLE READINGS FOR SODIUM AND THE LOT MET ALL RELEASE CRITERIA WITH NO DEVIATIONS DURING MANUFACTURING. A REVIEW OF THE COMPLAINT DATA SHOWED THERE WERE 4 COMPLAINTS FOR THIS ROTOR FROM THE SAME LOT REPORTED FOR ALLEGED HIGH SODIUM RESULTS. (B)(4). THERE HAVE BEEN NO REPORTED PATIENT IMPACT CONTRIBUTING TO PATIENT INJURY OR HOSPITALIZATION. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    THE CUSTOMER A HEALTHCARE PROFESSIONAL REPORTED UNEXPECTED HIGH SODIUM (NA+). THE PATIENT WAS TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990080 PICCOLO COMPREHENSIVE METABOLIC PANEL PICCOLO ROTOR JGS ABAXIS, INC 400-0028 2066AB0 EABA40000281

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown