BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZO TEST STRIPS

    MDR report key: 7616876 · Received June 19, 2018

    Report

    Report Number
    1832216-2018-00001
    Event Type
    Injury
    Date Received
    June 19, 2018
    Date of Event
    May 22, 2018
    Report Date
    May 29, 2018
    Manufacturer
    TECO DIAGNOSTICS
    Product Code
    JMT
    PMA / PMN Number
    K100024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ON 6/4/2018 A MAILER WAS SENT TO THE CONSUMER TO RETURN ANY UNUSED PORTION OF THE PRODUCT. TO DATE THE ITEM HAS NOT BEEN RECEIVED BY IHEALTH. BASED ON THE TIMELINE THE CONSUMER REPORTED, IT APPEARS THAT HE HAD THE URINE CULTURE PERFORMED THE SAME DAY AS THE DIPSTICK, THUS THERE WAS NO DELAY IN TREATMENT AND NO ADVERSE OUTCOME RELATED TO THE FALSE NEGATIVE RESULT. THE PRODUCT INSERT CLEARLY STATES THE LIMITATIONS OF THE TEST AND THE NEED TO CONSULT A PHYSICIAN FOR PERSISTENT SYMPTOMS. THUS, THIS CONSUMER DID NOT UNDERGO ANY ADVERSE EXPERIENCE AS A DIRECT RESULT OF USING THE PRODUCT, AND THUS THERE IS NO RELATIONSHIP BETWEEN THIS ADVERSE EVENT AND USE OF THE PRODUCT. ADDITIONALLY, ALTHOUGH THE PATIENT DENIES HAVING A BLOOD CULTURE, HE DID MENTION "UNSPECIFIED BLOOD TESTS" AND WAS DIAGNOSED WITH "GRAM NEGATIVE BACTEREMIA," A DIAGNOSIS THAT CAN ONLY BE OBTAINED VIA BLOOD CULTURE. IT IS LIKELY HE HAD A URINE CULTURE AT (B)(6)AND A BLOOD CULTURE AT THE HOSPITAL AS AN INPATIENT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED FROM AN ADULT MALE CONSUMER OF UNSPECIFIED AGE VIA TELEPHONE ON 29-MAY-2018 WITH FURTHER INFORMATION OBTAINED VIA TELEPHONE ON 30-MAY-2018. HIS PAST AND CURRENT MEDICAL HISTORY IS SIGNIFICANT FOR DIABETES (TYPE II), HYPERTENSION, PARATHYROIDECTOMY, PACEMAKER PLACEMENT, CARDIAC STENTS (X2), UNSPECIFIED HEART VALVE REPLACEMENTS, AND CAROTID ENDARTERECTOMY. THE CONSUMER WAS A POOR HISTORIAN AND WAS UNABLE TO PROVIDE PRECISE DETAILS OF HIS ADVERSE EXPERIENCE. THE CONSUMER USED AZO TEST STRIPS ONE TIME ON (B)(6) 2018 BECAUSE HE WAS EXPERIENCING PAINFUL URINATION, "URINATION BLOCKAGE," AND "URINATION LEAKAGE." THE STRIP SHOWED A NEGATIVE RESULT. HE CALLED HIS PHYSICIAN WHO SUGGESTED USING A "DIFFERENT" PRODUCT. THE SECOND PRODUCT PRODUCED A POSITIVE RESULT. THE CONSUMER WENT TO THE EMERGENCY ROOM, FROM WHERE HE WAS ADMITTED TO THE HOSPITAL FOR FIVE DAYS. HE STATED THAT HIS HOSPITAL DIAGNOSIS AND TREATMENT WERE FOR GRAM NEGATIVE BACTEREMIA. WHILE HOSPITALIZED, HE RECEIVED INTRAVENOUS ANTIBIOTICS, AND A FOLEY CATHETER WAS PLACED. TESTS PERFORMED WERE A TRANSESOPHAGEAL ECHOCARDIOGRAM, ANOTHER UNSPECIFIED ECHOCARDIOGRAM, AN UNSPECIFIED COMPUTED TOMOGRAPHY SCAN, AND UNSPECIFIED BLOODWORK. RESULTS OF THESE TESTS WERE UNREMARKABLE. THE HOSPITAL PHYSICIAN RECOMMENDED A DOPPLER SCAN OF HIS CAROTID ARTERIES, BUT THE CONSUMER REFUSED. HE WAS RELEASED FROM THE HOSPITAL WITH A PRESCRIPTION FOR ORAL ANTIBIOTICS. AT THE TIME OF THE TELEPHONE CONTACT, THE PATIENT WAS "FEELING BETTER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457472 AZO TEST STRIPS AZO TEST STRIPS JMT TECO DIAGNOSTICS 18058ASM13

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O