BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID-19 AT HOME TEST

    MDR report key: 14282503 · Received May 3, 2022

    Report

    Report Number
    MW5109487
    Event Type
    Malfunction
    Date Received
    May 3, 2022
    Date of Event
    April 27, 2022
    Report Date
    April 30, 2022
    Manufacturer
    SD BIOSENSOR, INC.
    Product Code
    QKP
    UDI-DI
    08800111707728
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I DON'T KNOW IF THE ROCHE COVID-19 AT HOME TEST GAVE A FALSE POSITIVE OR NOT. ONSET (B)(6) 2022 P.M. MILD TO EQUIVOCAL SYMPTOMS. IND = INDIVIDUAL (ALL SAME HOUSEHOLD.) THURSDAY, (B)(6) 2022: ROCHE COVID HOME TEST LOT: 53K32D1T1, EXP: 2022-08-09, RESULTS: IND 1 = (+) POS, IND 2 = (-) NEG. IHEALTH COVID HOME (DIDN'T GET LOT# BEFORE DISCARDING BOX BUT NOT EXPIRED AND MAY HAVE BOUGHT SAME TIME AS 211CO21215) TEST RESULTS: IND 1 = (-) NEG, IND 2 = (-) NEG, IND 3 (UNKNOWN BRAND) = (-) NEG. FRIDAY, (B)(6) 2022 BIDMC ALINITY SARS-COV-2 REAL TIME RT-PCR ASSAY. IND 1 (COLL (B)(6) 2022) = (-) NEG ROCHE LOT: 53K32D1T1, EXP: 2022-08-09, IND 1 = (+) POS ON/GO ACCESS BIO LOT: CP21L76, EXP: APR 2022, RESULTS: IND 1 = (-) NEG SATURDAY, (B)(6) 2022, ROCHE LOT: 53K32D1T1, EXP: 2022-08-09, IND 1 = (-) NEG. BIDMC ALINITY SARS-COV-2 REAL TIME RT-PCR ASSAY. IND 1 (COLL (B)(6) 2022) = (-) NEG. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1679192 COVID-19 AT HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP SD BIOSENSOR, INC. 9901-NCOV-10G 53K32D1T1/SUB:1-BUFFER 53H32A1 08800111707728
    1679193 COVID-19 AT HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP SD BIOSENSOR, INC. 9901-NCOV-10G 53K32D1T1/SUB:1-BUFFER 53H32A1 08800111707728

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Other