BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 13586373 · Received February 23, 2022

    Report

    Report Number
    3004464228-2022-03121
    Event Type
    Injury
    Date Received
    February 23, 2022
    Date of Event
    February 18, 2022
    Report Date
    February 18, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K192659
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE SKIN IRRITATION. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD IS ISO10993 COMPLIANT, UNDERGOING CYTOTOXICITY, SENSITIZATION, GENOTOXICITY, HEMOLYSIS, IRRITATION OR INTRACUTANEOUS REACTIVITY, SYSTEMIC TOXICITY, AND IMPLANTATION EFFECTS TESTING. THE OMNIPOD IS STERILIZED WITH 100% ETHYLENE OXIDE GAS WITH A STERILITY ASSURANCE LEVEL OF 10-6  PER ISO11135  AND EO RESIDUAL LEVELS IN COMPLIANCE WITH ISO10993. EACH LOT  IS CONFIRMED TO MEET REQUIREMENTS FOR NON-PYROGENICITY PER ISO10993 AND STERILITY PER ISO11135 PRIOR TO RELEASE.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE SKIN IRRITATION. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD IS ISO10993 COMPLIANT, UNDERGOING CYTOTOXICITY, SENSITIZATION, GENOTOXICITY, HEMOLYSIS, IRRITATION OR INTRACUTANEOUS REACTIVITY, SYSTEMIC TOXICITY, AND IMPLANTATION EFFECTS TESTING. THE OMNIPOD IS STERILIZED WITH 100% ETHYLENE OXIDE GAS WITH A STERILITY ASSURANCE LEVEL OF 10-6  PER ISO11135  AND EO RESIDUAL LEVELS IN COMPLIANCE WITH ISO10993. EACH LOT  IS CONFIRMED TO MEET REQUIREMENTS FOR NON-PYROGENICITY PER ISO10993 AND STERILITY PER ISO11135 PRIOR TO RELEASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SKIN IRRITATION CAUSING EXCESSIVE ITCHING AND CLEAR LIQUID DRAINAGE FROM A SCAB HAD OCCURRED WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS ON THE ARM. BLOOD GLUCOSE LEVELS WERE 315 MG/DL. SYMPTOMS BEGAN 1 DAY INTO USAGE. THE AFFECTED AREA WAS SLIGHTLY LARGER THAN THE POD. PATIENT VISITED PHYSICIAN AND WAS PRESCRIBED DOXYCYCLINE HYC 100 MG AND WAS TOLD TO USE TWICE A DAY UNTIL IT WAS GONE. THEY WERE ALSO TOLD TO USE MUPIROCIN USP, 2% CREAM AS NEEDED AS LONG AS BLISTER IS THERE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SKIN IRRITATION CAUSING EXCESSIVE ITCHING AND CLEAR LIQUID DRAINAGE FROM A SCAB HAD OCCURRED WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS ON THE ARM. BLOOD GLUCOSE LEVELS WERE 315 MG/DL. SYMPTOMS BEGAN 1 DAY INTO USAGE. THE AFFECTED AREA WAS SLIGHTLY LARGER THAN THE POD. PATIENT VISITED PHYSICIAN AND WAS PRESCRIBED DOXYCYCLINE HYC 100 MG AND WAS TOLD TO USE TWICE A DAY UNTIL IT WAS GONE. THEY WERE ALSO TOLD TO USE MUPIROCIN USP, 2% CREAM AS NEEDED AS LONG AS BLISTER IS THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930667 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1C07212141 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention