BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C TOTAL BILIRUBIN REAGENT KIT

    MDR report key: 12087280 · Received June 29, 2021

    Report

    Report Number
    3002809144-2021-00399
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 21, 2021
    Report Date
    August 16, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    CIG
    UDI-DI
    00380740158415
    PMA / PMN Number
    K121985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF TICKETS DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR LOT 58870UQ01. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. AS PART OF TROUBLESHOOTING THE CUSTOMER REMOVED THE SUSPECTED WEDGE AND REPLACED IT WITH A NEW ONE SAME LOT. AFTER REPLACING THE WEDGE QUALITY CONTROLS AND PATIENT SAMPLES WERE IN THE NORMAL RANGE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C TOTAL BILIRUBIN REAGENT LOT 58870UQ01 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C TOTAL BILIRUBIN RESULTS FOR MULTIPLE SAMPLES AFTER THE QUALITY CONTROLS WERE FOUND TO BE OUT OF RANGE ON (B)(6) 2021. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 81.08 UMOL/L, REPEAT = 6.8 UMOL/L. SID (B)(6) INITIAL RESULT = 75.15 UMOL/L, REPEAT = 5.1 UMOL/L. SID (B)(6) INITIAL RESULT = 70.42 UMOL/L, REPEAT = 7.2 UMOL/L. SID (B)(6) INITIAL RESULT = 65.26 UMOL/L, REPEAT = 6.6 UMOL/L. SID (B)(6) INITIAL RESULT = 73.76 UMOL/L, REPEAT = 7.4 UMOL/L. SID (B)(6) INITIAL RESULT = 90.35 UMOL/L, REPEAT = 14 UMOL/L. SID (B)(6) INITIAL RESULT = 72.66 UMOL/L, REPEAT = 7.1 UMOL/L. SID (B)(6) INITIAL RESULT = 89.10 UMOL/L, REPEAT = 10 UMOL/L. SID (B)(6) INITIAL RESULT = 79.47 UMOL/L, REPEAT = 11 UMOL/L.. SID (B)(6) INITIAL RESULT = 72.92 UMOL/L, REPEAT = 4.8 UMOL/L. SID (B)(6) INITIAL RESULT = 85.37 UMOL/L, REPEAT = 12 UMOL/L. SID (B)(6) INITIAL RESULT = 94.81 UMOL/L, REPEAT = 16 UMOL/L. SID (B)(6) INITIAL RESULT = 179.40 UMOL/L, REPEAT = 33 UMOL/L. SID (B)(6) INITIAL RESULT = 133.11 UMOL/L, REPEAT = 13 UMOL/L. SID (B)(6) INITIAL RESULT = 91.82 UMOL/L, REPEAT = 11 UMOL/L. SID (B)(6) INITIAL RESULT = 70.18 UMOL/L, REPEAT = 9.8 UMOL/L. SID (B)(6) INITIAL RESULT = 108.58 UMOL/L, REPEAT = 5.9 UMOL/L. SID (B)(6) INITIAL RESULT = 115.80 UMOL/L, REPEAT = 11 UMOL/L. SID (B)(6) INITIAL RESULT = 75.88 UMOL/L, REPEAT = 6.5 UMOL/L. SID (B)(6) INITIAL RESULT = 52.01 UMOL/L, REPEAT = 3.5 UMOL/L. SID (B)(6) INITIAL RESULT = 102.99 UMOL/L, REPEAT = 6.7 UMOL/L. SID (B)(6) INITIAL RESULT = 55.27 UMOL/L, REPEAT = 7.2 UMOL/L. SID (B)(6) INITIAL RESULT = 101.92 UMOL/L, REPEAT = 3.7 UMOL/L. SID (B)(6) INITIAL RESULT = 79.51 UMOL/L, REPEAT = 5.1 UMOL/L. SID (B)(6) INITIAL RESULT = 90.24 UMOL/L, REPEAT = 8.7 UMOL/L. SID (B)(6) INITIAL RESULT = 144.55 UMOL/L, REPEAT = 6.3 UMOL/L. SID (B)(6) INITIAL RESULT = 143.02 UMOL/L, REPEAT = 24 UMOL/L. SID (B)(6) INITIAL RESULT = 66.14 UMOL/L, REPEAT = 5.5 UMOL/L. SID (B)(6) INITIAL RESULT = 70.90 UMOL/L, REPEAT = 5.6 UMOL/L. SID (B)(6) INITIAL RESULT = 50.62 UMOL/L, REPEAT = 6.7 UMOL/L. SID (B)(6) INITIAL RESULT = 88.55 UMOL/L, REPEAT = 11 UMOL/L. SID (B)(6) INITIAL RESULT = 93.98 UMOL/L, REPEAT = 11 UMOL/L. SID (B)(6) INITIAL RESULT = > 420.00 UMOL/L, REPEAT = 97 UMOL/L. SID (B)(6) INITIAL RESULT = 237.48 UMOL/L, REPEAT = 41 UMOL/L. SID (B)(6) INITIAL RESULT = 67.72 UMOL/L, REPEAT = 10 UMOL/L. SID (B)(6) INITIAL RESULT = 90.38 UMOL/L, REPEAT = 9.2 UMOL/L.. SID (B)(6) INITIAL RESULT = 113.38 UMOL/L, REPEAT = 12 UMOL/L. SID (B)(6) INITIAL RESULT = 109.13 UMOL/L, REPEAT = 5.6 UMOL/L. SID (B)(6) INITIAL RESULT = 121.70 UMOL/L, REPEAT = 7.5 UMOL/L. SID (B)(6) INITIAL RESULT = 847.43 UMOL/L, REPEAT = 97 UMOL/L. SID (B)(6) INITIAL RESULT = 112.02 UMOL/L, REPEAT = 15 UMOL/L. SID (B)(6) INITIAL RESULT = 62.23 UMOL/L, REPEAT = 6.2 UMOL/L. SID (B)(6) INITIAL RESULT = 106.46 UMOL/L, REPEAT = 9.7 UMOL/L. SID (B)(6) INITIAL RESULT = 94.49 UMOL/L, REPEAT = 11 UMOL/L. SID (B)(6) INITIAL RESULT = 65.56 UMOL/L, REPEAT = 8.1 UMOL/L. SID (B)(6) INITIAL RESULT = 91.48 UMOL/L, REPEAT = 14 UMOL/L . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982624 ALINITY C TOTAL BILIRUBIN REAGENT KIT DIAZO COLORIMETRY, BILIRUBIN CIG ABBOTT GMBH 04V5121 58870UQ01 00380740158415

    Patients

    Seq Age Sex Outcome Treatment
    1 ALNTY C PROCESSING MODU, 03R67-01, AC01541.| ALNTY C PROCESSING MODU, 03R67-01, AC01541.