BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID-19 AT-HOME TEST

    MDR report key: 15607882 · Received October 14, 2022

    Report

    Report Number
    1823260-2022-03160
    Event Type
    Malfunction
    Date Received
    October 14, 2022
    Date of Event
    September 16, 2022
    Report Date
    October 14, 2022
    Manufacturer
    SD BIOSENSOR, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210661
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OCCUPATION IS PATIENT/CONSUMER: THE CONSUMER DID NOT MIX THE SWAB INSIDE OF THE TEST TUBE TEN TIMES AFTER SWABBING BOTH OF HER NOSTRILS, SHE DID NOT SQUEEZE THE SIDE OF THE TEST TUBE WITH HER INDEX FINGER AND THUMB WHILE SLOWLY REMOVING THE SWAB FROM THE TEST TUBE, AND SHE DID NOT SECURELY PLACE THE NOZZLE CAP ONTO THE TEST TUBE. PRODUCT LABELING STATES: "INSERT THE SWAB INTO THE TUBE 10X UNTIL THE SOFT PAD IS IN THE LIQUID. SQUEEZE THE TUBE AT THE BOTTOM AND HOLD IT TIGHT. THEN STIR THE SWAB MORE THAN 10 TIMES. THIS IS TO TRANSFER THE BIOLOGICAL MATERIAL FROM THE SWAB TO THE LIQUID. REMOVE THE SWAB WHILE SQUEEZING THE SIDES OF THE TUBE TO EXTRACT THE LIQUID FROM THE SWAB. WARNING!: FAILURE TO SQUEEZE THE TUBE CAN LEAD TO INCORRECT RESULTS DUE TO EXCESS BUFFER IN THE SWAB. DISPOSE OF THE SWAB AND SEAL THE TUBE SECURELY WITH THE NOZZLE CAP." THE CASE HAS BEEN SENT TO THE MANUFACTURER FOR INVESTIGATION. A FALSE NEGATIVE MAY OCCUR WHEN SAMPLING IS NOT PERFORMED AS DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU). THE LIMIT OF DETECTION VARIES DEPENDING ON THE TYPE OF TEST. A NEGATIVE RESULT MAY OCCUR DUE TO AN INSUFFICIENT AMOUNT OF VIRUS IN THE SAMPLE. IN GENERAL, THE RAPID AG TEST RESULT SHOULD NOT BE THE SOLE BASIS FOR THE DIAGNOSIS; DEPENDING ON THE SITUATION CONFIRMATORY TESTING IS REQUIRED (PCR).

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE COVID-19 AT-HOME TEST COMPARED TO A TEST PERFORMED AT A HOSPITAL. ON (B)(6) 2022, IN THE MORNING, THE CONSUMER HAD A "SARS COV 2 DETECTING TEST" PERFORMED AT A HOSPITAL AND THE RESULT WAS POSITIVE. THE TYPE OF TEST USED WAS UNKNOWN TO THE CONSUMER. ON (B)(6) 2022, IN THE AFTERNOON, THE CONSUMER PERFORMED A COVID-19 AT-HOME TEST AND THE RESULT WAS NEGATIVE. NO OTHER INFORMATION CAN BE PROVIDED. NO ADDITIONAL INFORMATION ABOUT TREATMENT AND OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887418 COVID-19 AT-HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP SD BIOSENSOR, INC. NA 53K32C2T11

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female AMLODIPINE| CARBAMAZEPINE| CITALOPRAM| METOPROLOL