BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM HTLV-I/HTLV-II

    MDR report key: 2223133 · Received August 25, 2011

    Report

    Report Number
    1415939-2011-00538
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MTP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED FIVE PATIENT SAMPLES TO BE USED IN THIS EVALUATION. WESTERN BLOT TESTING WAS PERFORMED ON THESE SAMPLES AND FOUR OF THE SAMPLES GENERATED (B)(6) RESULTS WHILE ONE SAMPLE GENERATED (B)(6) RESULTS (B)(6). THE WESTERN BLOT RESULT FOR THIS DISCREPANT SAMPLE DOES NOT MEET THE PRISM PACKAGE INSERT CRITERIA FOR INTERPRETATION AS (B)(6) FOR ANTI-HTLV. AN EVALUATION OF FIELD DATA REPORTED TO THE PRISM METRICS DATABASE FOR PRISM HTLV-I/HTLV-II REAGENT LOT 01876M500 WAS NEXT PERFORMED. FOR LOT 01876M500, A TOTAL OF 543,154 SAMPLES HAD BEEN TESTED ACROSS MULTIPLE CUSTOMER SITES AT THE TIME OF THE REVIEW. (B)(4). A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE PRISM HTLV-I/HTLV-II PACKAGE INSERT (B)(4) CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. BASED ON THE RESULTS OF THE CURRENT EVALUATION, THE PRISM HTLV-I/HTLV-II REAGENT KIT LOT 01876M500 IS PERFORMING ACCORDING TO PRODUCT LABEL CLAIMS. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A SAMPLE WAS RECEIVED FOR PLATELETPHERESIS FROM ONE DONOR AND GENERATED FALSE REPEAT (B)(6) RESULTS WITH THE PRISM HTLV REAGENT LOT 01876M500 (CUT-OFF VALUE IS 1.00 S/CO): SID: (B)(6), PRISM 01143: LOT 01876M500, (B)(6); PRISM 01401: LOT 01876M500, (B)(6); PRISM 0114: LOT 01920M500, (B)(6). THE ISSUE OCCURRED ON TWO DIFFERENT PRISM ANALYZERS WITH THE SAME REAGENT LOT. WHEN THE CUSTOMER SWITCHED TO REAGENT LOT 01920M500, THE EXPECTED (B)(6) RESULTS WERE GENERATED. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISM HTLV-I/HTLV-II MTP ABBOTT LABORATORIES 01876M500

    Patients

    Seq Age Sex Outcome Treatment
    1 PRISM ANALYZER LN:06A36-04 SN (B)(4)| PRISM ANALYZER LN:06A36-04 SN (B)(4)| PRISMHTLV-I/II LN: 06E50-68 LOT: 01920M500| PRISM ANALYZER LN:06A36-04 SN (B)(4)| PRISM HTLV LN: 06E50-68 LOT: 01920M500| PRISM ANALYZER LN:06A36-04 SN (B)(4)