BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 12344567 · Received August 19, 2021

    Report

    Report Number
    3002809144-2021-00497
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    July 11, 2021
    Report Date
    August 30, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ANALYZER AND REPLACEMENT OF THE HIGH CONCENTRATION WASTE PERISTALTIC PUMP TUBING DUE TO CUVETTES OVERFLOWING AT CUVETTE WASH NOZZLE. THE PART TUBING, PERISTALTIC HEAD (ROHS) (7-202464-01) WAS LIKELY CAUSE PART, WHICH RESOLED THE ISSUE. A REVIEW OF THE ALINITY CI PROCESSING MODULE, SERIAL NUMBER (B)(6) SERVICE HISTORY FOUND (1) ADDITIONAL SERVICE TICKET THAT IS ASSOCIATED WITH THE CURRENT COMPLAINT. A REVIEW OF TRACKING AND TRENDING OF THE ALINITY C PROCESSING MODULE DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE TUBING, PERISTALTIC HEAD (ROHS). A REVIEW OF HISTORICAL DATA REVEALED NO TRENDS, SYSTEMIC ISSUES, OR RELATED NONCONFORMANCES. THE ALINITY CI-SERIES OPERATIONS MANUAL AND ALINITY C SERVICE DOCUMENTATION PROVIDE ADEQUATE INFORMATION REGARDING THE TROUBLESHOOTING OF ERRATIC/DISCREPANT RESULTS AND THE REMOVAL, REPLACEMENT AND VERIFICATION OF PART NUMBER 7-202464-01 TUBING, PERISTALTIC HEAD (ROHS). A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ALINITY CI PROCESSING MODULE, SERIAL NUMBER (B)(6), OR THE TUBING, PERISTALTIC HEAD (ROHS).

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS IS CROSS REFERENCE 3002809144-2021-00459-01 FOR LIKELY CAUSE LIST NUMBER 08P19-20.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS ON ALINITY C PROCESSING MODULE FOR ONE MALE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 SID (B)(6) INITIAL=3.46 MMOL/L /REPEATED=0.66 MMOL/L /REPEATED ON ANOTHER ALINITY=0.66 MMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238285 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT GMBH 03R6701 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 ALNTY C MAGNESIUM 720T, 08P19-20, (B)(4)| ALNTY C MAGNESIUM 720T, 08P19-20, (B)(4)