BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELISWAB COVID-19 RAPID TEST

    MDR report key: 14465243 · Received May 21, 2022

    Report

    Report Number
    3004142665-2022-00023
    Event Type
    Injury
    Date Received
    May 21, 2022
    Date of Event
    May 14, 2022
    Report Date
    May 20, 2022
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF MEDWATCH REPORT MW5109755 WAS NOTED TO BE (B)(4) 2022. CONSUMER PROVIDED THE LOT NUMBER OF THE INTELISWAB TEST KIT (21036-01X) AND EXPIRATION DATE IS 03/22/2022. CONSUMER DID NOT PROVIDE DATE THEY USED THE INTELISWAB TESTS.

    Additional Manufacturer Narrative · 0

    5/20/22-DATE OF MEDWATCH REPORT MW5109755 WAS NOTED TO BE 5/14/2022. CONSUMER PROVIDED THE LOT NUMBER OF THE INTELISWAB TEST KIT (21036-01X) AND EXPIRATION DATE IS 03/22/2022. CONSUMER DID NOT PROVIDE DATE THEY USED THE INTELISWAB TESTS. 6/6/2022- OTI EMAILED CONSUMER ON 5/31/2022 TO GATHER MORE INFORMATION ABOUT THE EVENT. THE CONSUMER STATED THEY USED THE INTELISWAB TEST PRIOR TO EXPIRY. THE CONSUMER STATED THAT THEY WENT TO THE (B)(6) HOSPITAL EMERGENCY ROOM ON (B)(6) 2022 TO REPORT SYMPTOMS OF HEADACHE, BURNING IN NOSE AND EAR PAIN. CONSUMER RECEIVED A DR. NOTE TO ABSTAIN FROM TESTING WITH A NASAL SWAB AND TO REQUEST AN ALTERNATE SALIVA TEST. THE CONSUMER STATED THEY PERFORMED THE TEST USING THE INSTRUCTIONS ON THE PACKAGE INSERT. CURRENTLY OTI IS EVALUATING CHANGING THE INTELISWAB IFU TO REDUCE RISK OF FUTURE EVENTS. AT THIS TIME, NO FURTHER INFORMATION IS EXPECTED BY THIS CONSUMER IN ORDER TO CONTINUE AN INVESTIGATION. THIS COMPLAINT FILE WILL BE CLOSED INTERNALLY.

    Description of Event or Problem · 0

    OTI RECEIVED MEDWATCH REPORT MW5109755, VIA EMAIL FROM THE FDA. CONSUMER VOLUNTARILY SUBMITTED THE MDR FOR INTELISWAB. CONSUMER STATED AFTER USING INTELISWAB THEY STARTED HAVING SINUS, HEADACHE, BLOODY NOSE AND EAR PAIN. CONSUMER STATED THE SYMPTOMS WOULD LAST THE REMAINDER OF TEST DAY, THE FOLLOWING DAY AND ON THE THIRD DAY ONLY A LITTLE REMAINDER OF BLOOD REMAINED IN THE NOSE. CONSUMER STATED THEY USED THE TEST EXACTLY AS DESCRIBED IN THE INSTRUCTIONS EXCEPT THE CONSUMER WAS ONLY REQUIRED TO USE ONE SWAB IN THE KIT PER WEEK AS LONG AS THEY TESTED NEGATIVE. CONSUMER TOOK A TOTAL OF 5 TESTS. AS THE COVID LEVELS WENT DOWN IN THE COMMUNITY, THE CONSUMER STOPPED TESTING.

    Description of Event or Problem · 0

    OTI RECEIVED MEDWATCH REPORT MW5109755, VIA EMAIL FROM THE FDA. CONSUMER VOLUNTARILY SUBMITTED THE MDR FOR INTELISWAB. CONSUMER STATED AFTER USING INTELISWAB THEY STARTED HAVING SINUS, HEADACHE, BLOODY NOSE AND EAR PAIN. CONSUMER STATED THE SYMPTOMS WOULD LAST THE REMAINDER OF TEST DAY, THE FOLLOWING DAY AND ON THE THIRD DAY ONLY A LITTLE REMAINDER OF BLOOD REMAINED IN THE NOSE. CONSUMER STATED THEY USED THE TEST EXACTLY AS DESCRIBED IN THE INSTRUCTIONS EXCEPT THE CONSUMER WAS ONLY REQUIRED TO USE ONE SWAB IN THE KIT PER WEEK AS LONG AS THEY TESTED NEGATIVE. CONSUMER TOOK A TOTAL OF 5 TESTS. AS THE COVID LEVELS WENT DOWN IN THE COMMUNITY, THE CONSUMER STOPPED TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153171 INTELISWAB COVID-19 RAPID TEST INTELISWAB QKP ORASURE TECHNOLOGIES, INC. 21036-01X

    Patients

    Seq Age Sex Outcome Treatment
    1 Male