BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 9660849 · Received February 3, 2020

    Report

    Report Number
    1221359-2020-00007
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    December 31, 2019
    Report Date
    January 31, 2020
    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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 113490 WITH THE FOLLOWING INTERNAL SERUM/PLASMA CONTROL SAMPLES: (B)(6). ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOT 113490 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE RELATED TO LOT NUMBER 113490 SHOWED THAT THE COMPLAINT RATE IS 0.002%. THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. THE RESULTS OBTAINED MAY POSSIBLY BE RELATED TO THE PATIENT SAMPLE. THE SAMPLE MAY HAVE CONTAINED SPECIFIC SUBSTANCES WHICH MAY HAVE AFFECTED THE RESULTS. THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN LABELED CLAIMS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A (B)(6) RESULT WITH THE ALERE DETERMINE (B)(6) COMBO ASSAY. THE CUSTOMER REPORTED THAT A MALE PATIENT GENERATED A (B)(6) AG/AB RESULT ON A WHOLE BLOOD SAMPLE WITH THE ALERE DETERMINE (B)(6) COMBO ASSAY. THE CUSTOMER REPORTED THE "PATIENT TESTED POSITIVE FOR PNEUMOCYSTIS CARINII PNEUMONIA WHICH IS USUALLY ASSOCIATED WITH (B)(6)." ADDITIONAL HIV TESTING WAS PERFORMED ON A 5TH GENERATION MULTIPLEX FLOW IMMUNOASSAY (BIOPLEX), GENERATING POSITIVE/REACTIVE RESULTS. IT IS UNKNOWN IF TESTING WAS PERFORMED ON THE ORIGINAL WHOLE BLOOD SAMPLE. NOTE: THE FOLLOWING STATEMENT REGARDING SAMPLE TYPE IS CAPTURED FROM THE BIO-RAD BIOPLEX® 2200 SYSTEM HIV AG-AB INSTRUCTIONS FOR USE: "WARNING: FDA HAS APPROVED THIS TEST FOR USE WITH SERUM AND PLASMA SPECIMENS ONLY. USE OF THIS TEST KIT WITH SPECIMENS OTHER THAN THOSE SPECIFICALLY APPROVED FOR USE WITH THIS TEST KIT MAY RESULT IN INACCURATE TEST RESULTS." REPEAT TESTING WITH THE ORIGINAL WHOLE BLOOD SAMPLE ON THE SAME KIT LOT OF ALERE DETERMINE (B)(6) COMBO ASSAY GENERATED POSITIVE/REACTIVE (AG/AB NOT OTHERWISE SPECIFIED) RESULTS. THE CUSTOMER ALSO REPORTED THAT A PLASMA SAMPLE FROM THE PATIENT PRODUCED (B)(6) (AG/AB NOT OTHERWISE SPECIFIED) RESULTS WITH ALERE DETERMINE (B)(6) COMBO. THE CUSTOMER REPORTED THAT THE PATIENT WAS NOT A KNOWN (B)(6) PATIENT. THE PATIENT RECEIVED ART BASED ON THE ALERE DETERMINE(B)(6) AG/AB COMBO AND BIOPLEX TESTING RESULTS. IT IS UNKNOWN IF THE PATIENT WAS TAKING BIOTIN AT THE TIME OF TESTING. PATIENT OUTCOME IS UNKNOWN. MULTIPLE ATTEMPTS TO GAIN INFORMATION WERE NOT SUCCESSFUL. PER THE ALERE DETERMINE (B)(6) AG/AB PRODUCT INSERT: DETECTION OF P24 MAY BE INHIBITED BY BIOTIN IN THE SAMPLE, CAUSING FALSE NEGATIVE RESULTS IN ACUTE INFECTION. THEREFORE, DO NOT TEST SAMPLES FROM PATIENTS WHO ARE TAKING BIOTIN. A NONREACTIVE RESULT DOES NOT PRECLUDE THE POSSIBILITY OF EXPOSURE TO (B)(6) OR INFECTION WITH (B)(6). THE PI INDICATES THAT NON-REACTIVE RESULTS DO NOT PRECLUDE THE POSSIBILITY OF EXPOSURE TO HIV OR INFECTION WITH HIV. THERE IS A RISK FOR THE PATIENT NOT TO RECEIVE THE NECESSARY TREATMENT, WHICH MAY CONTRIBUTE TO SERIOUS IMPAIRMENT OF THE BODY AND/OR TO FURTHER SPREAD OF THE VIRUS. ADDITIONALLY, IT IS EXPECTED THAT TESTING THE SAME PATIENT SAMPLE OR A SECOND SAMPLE FROM THE SAME PATIENT TESTED ON THE SAME DAY AS THE ORIGINAL SAMPLE WOULD RETURN THE SAME RESULT. SINCE THIS CASE DOES NOT CONCERN PATIENT INJURY, THE INCIDENT IS CONSIDERED A MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125343 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV 1/2 AG/AB MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 113490 10811877010293

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR