BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISCREEN OFD SALIVA TEST

    MDR report key: 4583938 · Received March 9, 2015

    Report

    Report Number
    2027969-2015-00167
    Event Type
    Malfunction
    Date Received
    March 9, 2015
    Date of Event
    February 13, 2015
    Report Date
    February 13, 2015
    Manufacturer
    ABON BIOPHARM (HANGZHOU) CO., LTD
    Product Code
    MVO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THIS PRODUCT IS FOR FORENSIC USE ONLY AND THEREFORE IS 510(K) EXEMPT. INVESTIGATION: CUSTOMER'S OBSERVATION COULD NOT BE REPRODUCED WITH IN-HOUSE RETAIN PRODUCT. IN-HOUSE RETAIN PRODUCT WERE TESTED WITH DRUG FREE DONORS, THE TEST RESULTS DID NOT OBSERVED ANY ABNORMAL, INCLUDING SPONGE COLOR, SMELL, DEVICE APPEARANCE ETC. PER ISSUE, "DONOR IS ALLERGIC TO CORN SYRUP", DUE TO SPONGE'S TREATMENT PROCEDURES, IT DID NOT HAVE CORN SYRUP COMPONENT IN SPONGE. SPONGE WAS TREATED WITH SUCROSE WHICH SHARES A COMMON COMPONENT WITH CORN SYRUP. BOTH CORN SYRUP AND SUCROSE CONTAIN GLUCOSE. IT CANNOT BE RULED OUT THAT THIS INGREDIENT MAY HAVE CAUSED THE PATIENT'S ALLERGIC REACTION. THIS ISSUE WILL BE TRACKED AND TRENDED. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED AN ALLERGIC REACTION FROM USING THE ISCREEN OFD SALIVA TEST. RESULTS AS FOLLOWS: THE DISTRIBUTOR REPORTED THAT THE END-USER HAD A DONOR THAT HAD AN ALLERGIC REACTION AFTER USING THE ISCREEN OFD SALIVA TEST. THE DONOR REPORTS THAT HE IS ALLERGIC TO CORN SYRUP. THE DONOR HAD GONE HOME AFTER USING THE ORAL-FLUID TEST AND CALLED THE TEST PROVIDER BACK AFTER ABOUT 30 MINUTES BECAUSE HIS FACE STARTED TO SWELL. THE DONOR ASKED IF THE TEST COLLECTORS HAD CORN SYRUP IN THEM. THE DONOR WAS REPORTED TO HAVE TAKEN BENADRYL AND WAS DOING OKAY. KIT WAS PURCHASED IN (B)(6) 2014. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163031 ISCREEN OFD SALIVA TEST DRUGS OF ABUSE TEST MVO ABON BIOPHARM (HANGZHOU) CO., LTD DSB-765-011-ONW510 DOA3090278

    Patients

    Seq Age Sex Outcome Treatment
    1