BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 9639893 · Received January 28, 2020

    Report

    Report Number
    1221359-2020-00005
    Event Type
    Injury
    Date Received
    January 28, 2020
    Date of Event
    December 30, 2019
    Report Date
    December 29, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MZF
    UDI-DI
    10811877010293
    PMA / PMN Number
    BP120037-0
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B5, D3 & G1. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO ADDRESS THE CORRECTIONS TO THE INITIAL REPORT THAT WERE PREVIOUSLY SUBMITTED FOR AN INVALID RESULT ON A SOURCE PATIENT ASSOCIATED WITH A NEEDLESTICK INCIDENT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED AN INVALID RESULT ON THE SOURCE PATIENT FOR A NEEDLESTICK EVENT INVOLVING TWO (2) EMPLOYEES. THE CUSTOMER REPORTED THAT DURING AN INVESTIGATION INTO POTENTIAL EXPOSURE OF TWO EMPLOYEES INVOLVED IN A NEEDLESTICK INJURY, THE SOURCE PATIENT TESTED INVALID WITH THE ALERE DETERMINE HIV-1/2 AG/AB COMBO ON AN EDTA PLASMA SAMPLE BUT CONFIRMATION TESTING CONDUCTED ON THE SAME DAY ON THE BIORAD GENIUS AND ABBOTT ARCHITECT WERE POSITIVE/REACTIVE FOR HIV. THE CUSTOMER STATED THERE WAS NO VISIBLE CONTROL LINE BUT NOTED THAT "THERE WAS A LINE VISIBLE IN LTA (AB)" ON THE SOURCE PATIENT TEST STRIP. THE SOURCE SAMPLE WAS REPORTED AS EDTA BLOOD PLASMA, COLLECTED IN A 4 ML EDTA VACUTAINER. THE PLASMA WAS ADDED TO THE TEST STRIP WITH A CAPILLARY TUBE, WHICH IS AN OFF-LABEL TECHNIQUE. PER THE PRODUCT INSERT (PI), DISPOSABLE CAPILLARY TUBES ARE PROVIDED FOR THE COLLECTION AND TRANSFER OF FINGERSTICK WHOLE BLOOD SAMPLES. THE PI INSTRUCTS THE OPERATOR TO USE A PRECISION PIPETTE FOR SERUM OR PLASMA SAMPLES. "THE CUSTOMER REPORTED THAT INFORMATION IS NOT AVAILABLE FOR THE EMPLOYEES WHO SUSTAINED THE NEEDLESTICK INJURY. IT IS UNKNOWN IF THE EMPLOYEE WAS TESTED WITH THE ALERE DETERMINE HIV-1/2 AG/AB COMBO TEST. IT IS UNKNOWN IF ANY CONFIRMATION TESTING WAS PERFORMED ON THE EMPLOYEES. PATIENT GENDER, PREGNANCY STATUS, POSTEXPOSURE PROPHYLAXIS (PEP) / ART AND OUTCOME IS UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF AN ADVERSE EVENT OCCURRED. MULTIPLE ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL. PER THE CDC'S UPDATED U.S. PUBLIC HEALTH SERVICE GUIDELINES FOR THE MANAGEMENT OF OCCUPATIONAL EXPOSURES TO HIV AND RECOMMENDATIONS FOR POSTEXPOSURE PROPHYLAXIS: "RAPID DETERMINATION OF SOURCE PATIENT HIV STATUS PROVIDES ESSENTIAL INFORMATION ABOUT THE NEED TO INITIATE AND/OR CONTINUE PEP. REGARDLESS OF WHICH TYPE OF HIV TESTING IS EMPLOYED, ALL OF THE ABOVE TESTS ARE ACCEPTABLE FOR DETERMINATION OF SOURCE PATIENT HIV STATUS. ADMINISTRATION OF PEP SHOULD NOT BE DELAYED WHILE WAITING FOR TEST RESULTS. IF THE SOURCE PATIENT IS DETERMINED TO BE HIV NEGATIVE, PEP SHOULD BE DISCONTINUED AND NO FOLLOW-UP HIV TESTING FOR THE EXPOSED PROVIDER IS INDICATED. "INSUFFICIENT INFORMATION CANNOT RULE OUT SERIOUS INJURY OR POTENTIAL SERIOUS INJURY, THEREFORE THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY".

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), 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 INVALID RELATED TO LOT NUMBER 113490 SHOWED THAT THE COMPLAINT RATE IS (B)(4). 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. 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 NEEDLESTICK EVENT INVOLVING TWO (2) EMPLOYEES. THIS REPORT REPRESENTS TWO (2) OF TWO (2) NEEDLESTICK EVENTS. THE CUSTOMER REPORTED THAT AN EMPLOYEE WAS INVOLVED IN A NEEDLESTICK INJURY WHERE THE SOURCE PATIENT TESTED INVALID WITH THE ALERE DETERMINE HIV-1/2 AG/AB COMBO ON AN EDTA PLASMA SAMPLE. SOURCE PATIENT SAME DAY CONFIRMATION TESTING ON THE BIORAD GENIUS AND ABBOTT ARCHITECT WAS (B)(6). THE CUSTOMER STATED THERE WAS NO VISIBLE CONTROL LINE BUT NOTED THAT "THERE WAS A LINE VISIBLE IN LTA (AB)" ON THE SOURCE PATIENT TEST STRIP. THE SOURCE SAMPLE WAS REPORTED AS EDTA BLOOD PLASMA, COLLECTED IN A 4 ML EDTA VACUTAINER. THE PLASMA WAS ADDED TO THE TEST STRIP WITH A CAPILLARY TUBE, WHICH IS AN OFF-LABEL TECHNIQUE. PER THE PRODUCT INSERT (PI), DISPOSABLE CAPILLARY TUBES ARE PROVIDED FOR THE COLLECTION AND TRANSFER OF FINGERSTICK WHOLE BLOOD SAMPLES. THE PI INSTRUCTS THE OPERATOR TO USE A PRECISION PIPETTE FOR SERUM OR PLASMA SAMPLES. PI TEST PROCEDURE: "SERUM OR PLASMA SAMPLES: APPLY 50 [?]L OF SAMPLE (PRECISION PIPETTE) BY TOUCHING THE TIP OF THE PIPETTE TO THE SAMPLE PAD (MARKED BY THE ARROW SYMBOL). DO NOT ADD CHASE BUFFER WHEN USING SERUM OR PLASMA SPECIMENS." THE CUSTOMER REPORTED THAT INFORMATION IS NOT AVAILABLE FOR THE #2 EMPLOYEE WHO SUSTAINED THE NEEDLESTICK INJURY. IT IS UNKNOWN IF THE EMPLOYEE WAS TESTED WITH THE ALERE DETERMINE HIV-1/2 AG/AB COMBO TEST. IT IS UNKNOWN IF ANY CONFIRMATION TESTING WAS PERFORMED ON THE EMPLOYEE. PATIENT GENDER, PREGNANCY STATUS, POSTEXPOSURE PROPHYLAXIS (PEP)/ART AND OUTCOME IS UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF AN ADVERSE EVENT OCCURRED. EMPLOYEE OUTCOME IS UNKNOWN. MULTIPLE ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL. PER THE CDC'S UPDATED U.S. PUBLIC HEALTH SERVICE GUIDELINES FOR THE MANAGEMENT OF OCCUPATIONAL EXPOSURES TO HIV AND RECOMMENDATIONS FOR POSTEXPOSURE PROPHYLAXIS: "RAPID DETERMINATION OF SOURCE PATIENT HIV STATUS PROVIDES ESSENTIAL INFORMATION ABOUT THE NEED TO INITIATE AND/OR CONTINUE PEP. REGARDLESS OF WHICH TYPE OF HIV TESTING IS EMPLOYED, ALL OF THE ABOVE TESTS ARE ACCEPTABLE FOR DETERMINATION OF SOURCE PATIENT HIV STATUS. ADMINISTRATION OF PEP SHOULD NOT BE DELAYED WHILE WAITING FOR TEST RESULTS. IF THE SOURCE PATIENT IS DETERMINED TO BE HIV-NEGATIVE, PEP SHOULD BE DISCONTINUED AND NO FOLLOW-UP HIV TESTING FOR THE EXPOSED PROVIDER IS INDICATED." INSUFFICIENT INFORMATION CANNOT RULE OUT SERIOUS INJURY OR POTENTIAL SERIOUS INJURY, THEREFORE THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98694 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 Unknown