BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C MICROALBUMIN REAGENT KIT

    MDR report key: 16863273 · Received May 3, 2023

    Report

    Report Number
    3002809144-2023-00219
    Event Type
    Malfunction
    Date Received
    May 3, 2023
    Date of Event
    January 1, 2023
    Report Date
    July 11, 2023
    Manufacturer
    ABBOTT GMBH
    Product Code
    JIQ
    UDI-DI
    00380740135201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION REGARDING ALINITY C MICROALBUMIN RESULTS THAT WERE OFF BY 1 DECIMAL SPOT INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TICKET AND TRENDING REVIEW FOR THE ALINITY C MICROALBUMIN REAGENT DID NOT IDENTIFY ANY RELATED TRENDS. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMANCES. A LABELING REVIEW DETERMINED PRODUCT LABELING PROVIDES ADEQUATE INFORMATION REGARDING THE CUSTOMER ISSUE. AFTER THE FIELD SERVICE ENGINEER ASSISTED THE CUSTOMER TO CHANGE ALL THE APPLICABLE ALINITY C MICROALBUMIN UNIT OF MEASURE TO MG/DL FROM MG/L, NO FURTHER ISSUES HAVE BEEN NOTED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY C MICROALBUMIN REAGENT WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE MICROALBUMIN COLLEGE OF AMERICAN PATHOLOGISTS (CAP) SURVEY FAILED ON THE ALINITY C PROCESSING MODULE (B)(6), AS ALL RESULTS ON THE 5 MICROALBUMIN CAP CHALLENGE WERE FALSELY DEPRESSED AND OFF BY 1 DECIMAL PLACE. IT WAS DETERMINED THAT WHEN THE INSTRUMENT WAS FIRST INSTALLED, MG/L WAS USED FOR ALINITY C MICROALBUMIN AND AT SOME POINT IN TIME THE UNIT OF MEASURE CONFIGURATION WAS CHANGED TO MG/DL. THE CUSTOMER COMMUNICATED THAT ABBOTT ASSISTED THE CUSTOMER WITH THIS CONFIGURATION STEP. UPON FURTHER REVIEW, THE ACTUAL UNITS WERE CHANGED FOR THE ASSAY, BUT NOT FOR THE CALIBRATOR. THE CONFIGURATION VALUES WERE ALL UPDATED TO BE SYNCHRONOUS WITH THE MG/DL UNIT OF MEASURE FROM THE MG/L UNIT OF MEASURE. A DATA PULL OF ALL MICROALBUMIN SAMPLES REPORTED SINCE THE ASSAY WENT LIVE IN JANUARY 2023 WAS COMPLETED WITH A TOTAL OF 591 PATIENT SAMPLES. INITIAL REVIEW OF THE DATA DOES NOT INCLUDE DATA FROM JANUARY TO (B)(6) 2023 NOR DOES IT INCLUDE OBJECTIVE VALUES. CUSTOMER NORMAL RANGE UALB IS 0.5-29 MG/DL. THE CORRECTED RESULTS FROM THE REVIEWED DATA IS AS FOLLOWS. IN REVIEWING THE DATA: ABNORMAL TO NORMAL = 110 SPECIMENS, ABNORMAL TO ABNORMAL = 30 SPECIMENS, LESS THAN 5 = 68 SPECIMENS, GREATER THAN 200 = 5 SPECIMENS. THERE HAS BEEN NO KNOWN REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE MICROALBUMIN COLLEGE OF AMERICAN PATHOLOGISTS (CAP) SURVEY FAILED ON THE ALINITY C PROCESSING MODULE SN: (B)(6) AS ALL RESULTS ON THE 5 MICROALBUMIN CAP CHALLENGE WERE FALSELY DEPRESSED AND OFF BY 1 DECIMAL PLACE. IT WAS DETERMINED THAT WHEN THE INSTRUMENT WAS FIRST INSTALLED, MG/L WAS USED FOR ALINITY C MICROALBUMIN AND AT SOME POINT IN TIME THE UNIT OF MEASURE CONFIGURATION WAS CHANGED TO MG/DL. THE CUSTOMER COMMUNICATED THAT ABBOTT ASSISTED THE CUSTOMER WITH THIS CONFIGURATION STEP. UPON FURTHER REVIEW, THE ACTUAL UNITS WERE CHANGED FOR THE ASSAY, BUT NOT FOR THE CALIBRATOR. THE CONFIGURATION VALUES WERE ALL UPDATED TO BE SYNCHRONOUS WITH THE MG/DL UNIT OF MEASURE FROM THE MG/L UNIT OF MEASURE. A DATA PULL OF ALL MICROALBUMIN SAMPLES REPORTED SINCE THE ASSAY WENT LIVE IN JANUARY 2023 WAS COMPLETED WITH A TOTAL OF 591 PATIENT SAMPLES. INITIAL REVIEW OF THE DATA DOES NOT INCLUDE DATA FROM JANUARY TO FEBRUARY 20, 2023 NOR DOES IT INCLUDE OBJECTIVE VALUES. CUSTOMER NORMAL RANGE UALB IS 0.5-29 MG/DL. THE CORRECTED RESULTS FROM THE REVIEWED DATA IS AS FOLLOWS IN REVIEWING THE DATA: ¿ ABNORMAL TO NORMAL = 110 SPECIMENS ¿ ABNORMAL TO ABNORMAL = 30 SPECIMENS ¿ LESS THAN 5 = 68 SPECIMENS ¿ GREATER THAN 200 = 5 SPECIMENS. THERE HAS BEEN NO KNOWN REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811325 ALINITY C MICROALBUMIN REAGENT KIT TURBIDIMETRIC METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) JIQ ABBOTT GMBH 08P0420 00380740135201

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY C PROCESSING MODU, 03R67-01, AC05143| ALNTY C PROCESSING MODU, 03R67-01, AC05143.