BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 8887707 · Received August 13, 2019

    Report

    Report Number
    1221359-2019-00057
    Event Type
    Malfunction
    Date Received
    August 13, 2019
    Date of Event
    July 4, 2019
    Report Date
    August 13, 2019
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MZF
    UDI-DI
    10811877010293
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOTS: 102997, AND 108538 WITH THE FOLLOWING SERUM/PLASMA CONTROL SAMPLES: (B)(6). ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. THE CUSTOMER RETURNED THE PATIENT SAMPLE COLLECTED ON (B)(6) 2019. THE SAMPLE WAS TESTED WITH X1 DEVICE FROM EACH KIT LOT. BOTH TESTS YIELDED VALID, REACTIVE P24 ANTIGEN RESULTS. PLEASE NOTE: THE CUSTOMER STATED THEY STORED THE SAMPLES AT A REFRIGERATED TEMPERATURE SINCE COLLECTION. THE SAMPLE ARRIVED AT ABBOTT DIAGNOSTICS (B)(4) ON TESTED ON (B)(6) 2019. ACCORDING TO THE PACKAGE INSERT UNDER THE SECTION SPECIMEN STORAGE: SERUM AND PLASMA SPECIMENS MAY BE STORED AT ROOM TEMPERATURE (15- 30°C) FOR UP TO TWO DAYS BEFORE TESTING. IF TESTING WILL NOT BE PERFORMED WITHIN TWO DAYS OF SAMPLE COLLECTION, SERUM AND PLASMA SPECIMENS SHOULD BE STORED AT 2- 8°C IF THE TEST IS TO BE RUN WITHIN 7 DAYS OF COLLECTION. IF TESTING IS DELAYED MORE THAN 7 DAYS, THE SPECIMEN SHOULD BE FROZEN (-20°C OR COLDER). THE MANUFACTURING BATCH RECORDS FOR LOTS: 102997 AND 108538 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS (B)(6) RELATED TO LOT NUMBERS 102997 AND 108538 SHOWED THAT THE COMPLAINT RATE IS (B)(4)., RESPECTIVELY. THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. ABBOTT DIAGNOSTICS (B)(4), INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A (B)(6) RESULT ON A SERUM SAMPLE (COLLECTION DATE: (B)(6) 2019) WITH THE ALERE DETERMINE HIV-1/2 AG/AB COMBO TEST (KIT LOT # 102997) ON A MALE PATIENT. CONFIRMATORY TESTING FROM A SERUM SAMPLE (COLLECTION DATE: (B)(6) 2019) PRODUCED (B)(6) RESULTS WITH THE ABBOTT ARCHITECT; (B)(6) RESULTS WITH THE BIORAD GEENIUS; (B)(6) RESULTS WITH AN HIV-1 RNA QUALITATIVE ASSAY (NOT OTHERWISE SPECIFIED). REPEAT TESTING ON (B)(6) 2019 OF THE SERUM SAMPLES, COLLECTION DATES: (B)(6) 2019 AND (B)(6) 2019 WERE NEGATIVE WITH THE ALERE DETERMINE HIV-1/2 AG/AB COMBO TEST (KIT LOT # 102997). ADDITIONAL TESTING (SERUM SAMPLE, COLLECTION DATE: (B)(6) 2019) WAS NEGATIVE WITH THE ALERE DETERMINE HIV-1/2 AG/AB COMBO TEST ON (B)(6) 2019 WITH KIT LOT # 108538. TESTING OF THE SERUM SAMPLE, COLLECTION DATE: (B)(6) 2019, PRODUCED (B)(6) RESULTS WITH THE ABBOTT ARCHITECT AND (B)(6) RESULTS WITH THE BIORAD GEENIUS WHEN TESTED. NOTE: PACKAGE INSERT SPECIMEN STORAGE STATES: SERUM AND PLASMA SPECIMENS MAY BE STORED AT ROOM TEMPERATURE (15- 30°C) FOR UP TO TWO DAYS BEFORE TESTING. IF TESTING WILL NOT BE PERFORMED WITHIN TWO DAYS OF SAMPLE COLLECTION, SERUM AND PLASMA SPECIMENS SHOULD BE STORED AT 2- 8°C IF THE TEST IS TO BE RUN WITHIN 7 DAYS OF COLLECTION. IF TESTING IS DELAYED MORE THAN 7 DAYS, THE SPECIMEN SHOULD BE FROZEN (-20°C OR COLDER). MIX SPECIMEN WELL BY GENTLE INVERSION OF THE TUBE IMMEDIATELY BEFORE TESTING. TREATMENT AND PATIENT OUTCOME WERE NOT REPORTED. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681851 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV 1/2 AG/AB MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 102997 10811877010293

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR