BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKVUE DIPSTICK STREP A TEST KIT

    MDR report key: 2338098 · Received November 7, 2011

    Report

    Report Number
    2024674-2011-00002
    Event Type
    Injury
    Date Received
    November 7, 2011
    Date of Event
    April 1, 2011
    Report Date
    November 4, 2011
    Manufacturer
    QUIDEL CORP.
    Product Code
    GTZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER ANALYZED COMPLAINT DATA FROM THE PREVIOUS THREE (3) YEARS. NO TREND WAS IDENTIFIED FOR FALSE POSITIVE TEST RESULTS WITH THE QUICKVUE DIPSTICK STREP A PRODUCT.

    Description of Event or Problem · 1

    MOTHER OF (B)(6) MALE REPORTED THE FOLLOWING EVENTS. THE PATIENT WAS BROUGHT TO MEDICAL FACILITY MULTIPLE TIMES WITH SYMPTOMS OF NAUSEA AND VOMITING OVER A THREE-MONTH PERIOD DURING (B)(6) 2011. PATIENT THROAT SWABS WERE TESTED 6-7 TIMES WITH THE QUICKVUE DIPSTICK STREP A TEST AND RECEIVED POSITIVE TEST RESULTS IN EACH CASE. PATIENT WAS ISSUED ANTIBIOTICS AFTER MORE THAN ONE VISIT (MAY INCLUDE AMOXICILLIN AND CLINDAMYCIN). MOTHER INDICATED THAT SHE BELIEVED THE FACILITY HAD PERFORMED BACK-UP CELL CULTURE ON MORE THAN ONE THROAT SPECIMEN TAKEN FROM THE PATIENT, AND THE CULTURES WERE NEGATIVE FOR GROUP A STREPTOCOCCUS. HOWEVER, SHE (AS THE PARENT) DID NOT RECEIVE FORMAL NOTIFICATION OF THESE CULTURE RESULTS FROM THE FACILITY. PATIENT WAS TAKEN TO AN INFECTIOUS DISEASE DOCTOR AND ENT DOCTOR, AND A TONSILLECTOMY WAS LATER PERFORMED ON (B)(6) 2011 DUE TO NO APPARENT RESPONSE TO CLINDAMYCIN TREATMENT. MOTHER INDICATED THAT THE PATIENT TESTED POSITIVE FOR STREP A SINCE THE TONSILLECTOMY, HOWEVER IT WAS NOT SPECIFIED IF THIS TESTING WAS PERFORMED WITH THE QUICKVUE TEST. NO OTHER DIAGNOSIS HAS BEEN MADE REGARDING THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKVUE DIPSTICK STREP A TEST KIT QUICKVUE DIPSTICK STREP A TEST KIT GTZ QUIDEL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other