BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALERE ORATECT

    MDR report key: 6945902 · Received October 12, 2017

    Report

    Report Number
    2032598-2017-00001
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    September 13, 2017
    Report Date
    September 15, 2017
    Manufacturer
    AMEDITECH, INC.
    Product Code
    DJC
    PMA / PMN Number
    K103227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6) WITH USE OF A PRODUCT INDICATED FOR "FORENSIC USE ONLY". AMEDITECH MADE THE DECISION TO REPORT THIS EVENT TO THE AGENCY BASED ON THE SIMILARITY BETWEEN THE PRODUCT INVOLVED IN THIS EVENT AND ORATECT PRODUCTS MARKETED FOR IN VITRO DIAGNOSTIC USE IN THE UNITED STATES. THE UNITED STATES MARKETED PRODUCTS ARE IDENTIFIABLE BY THE CATALOG NUMBERS HM15, AOT-06, AND X11-AOT-06. DEVICE SIMILARITIES INCLUDE THE DETECTION ANALYTES USED TO OBTAIN TEST RESULTS, AND IDENTICAL SAMPLE COLLECTION PADS. THE SAMPLE COLLECTION PAD IS THE POINT OF CONTACT BETWEEN THE DEVICE AND THE PATIENT, AND IS THE LIKELY COMPONENT TO WHICH THE PATIENT MAY HAVE EXPERIENCED ALLERGIC SYMPTOMS. KLIGMAN MAXIMIZATION TESTING WAS PERFORMED ON THIS COLLECTION PAD IN 2014. THIS TESTING CATEGORIZED THE COLLECTION PAD WITH A GRADE 1 SENSITIZATION RATE, THE LOWEST AVAILABLE ALLERGIC POTENTIAL SCORE. THIS EVENT IS ALSO THE FIRST REPORTED ALLERGIC REACTION TO THIS DEVICE. GIVEN THE LOW ALLERGIC POTENTIAL CLASSIFICATION, AND LOW EVENT FREQUENCY IT WAS DETERMINED THAT NO CORRECTIVE OR PREVENTIVE ACTIONS WERE REQUIRED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) A TEST SAMPLE FOR DRUG SCREENING ON AN ORATECT XP DEVICE, CATALOG NUMBER PM21, LOT NUMBER U0827, WAS COLLECTED FROM A PATIENT. AFTER PROVIDING THE SAMPLE THE DONOR INFORMED THE TESTING TECHNICIANS THAT SHE WAS ALLERGIC TO MANY SUBSTANCES AND INDICATED THAT HER TONGUE HAD LOST FEELING, INDICATING A POSSIBLE ALLERGIC REACTION TO THE ORATECT DEVICE. THE PATIENT WAS MONITORED FOR SEVERAL MINUTES AND THE CLINICAL STAFF NOTED THAT NO FURTHER SYMPTOMS OCCURRED. THE PATIENT WAS THEN RELEASED. THE FOLLOWING DAY THE PATIENT CONSULTED A PHYSICIAN, NOTING THAT THE TONGUE NUMBNESS HAD NOT SUBSIDED. HER PHYSICIAN CONTACTED THE MANUFACTURER LOCAL REPRESENTATIVE REQUESTING A COPY OF THE MATERIAL SAFETY DATA SHEET FOR THE PRODUCT. THIS REQUEST WAS FORWARDED TO AMEDITECH, ON SEPTEMBER 15. A COPY OF THE MATERIAL SAFETY DATA SHEET WAS PROVIDED TO THE LOCAL REPRESENTATIVE AND FORWARDED TO THE PHYSICIAN ON SEPTEMBER 17. ON (B)(6) THE PATIENT HAD A FOLLOW UP VISIT WITH HER PHYSICIAN AND PRESENTED WITH A MILD RASH, IRRITATION TO ONE EYE, AND INDICATED THAT THE LOSS OF FEELING IN HER TONGUE PERSISTED. THE PHYSICIAN PRESCRIBED A TOPICAL SKIN CREAM AND MEDICATED EYE DROPS TO ADDRESS THE PATIENT'S SYMPTOMS. THREE FOLLOW-UP ATTEMPTS HAVE OCCURRED SINCE, HOWEVER NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724139 ALERE ORATECT ORATECT ORAL FLUID DRUG SCREEN DEVICE DJC AMEDITECH, INC. ORATECT XP U0827

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other