BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2221181 · Received August 17, 2011

    Report

    Report Number
    3004464228-2011-00404
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PDM WAS NOT RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE "CONTINUED" METER ERROR 2 ALERTS INITIATED BY THE DEVICE. PER THE OMNIPOD USER GUIDE, THERE ARE FOUR POSSIBLE CAUSES OF A METER ERROR 2 ALERT: PROBLEM WITH THE TEST STRIP; PROBLEM WITH THE METER; VERY HIGH BLOOD GLUCOSE (ABOVE 500MG/DL); HIGH CONTROL SOLUTION APPLIED WHEN TEMP IS TOO COLD. (THIS APPLIES ONLY TO CONTROL SOLUTION LABELED HIGH.). WITHOUT THE TEST STRIPS RETURNING FOR EVAL, WE ARE UNABLE TO CONCLUDE THAT THE METER ERROR 2 ALERTS HAD RESULTED FROM A STRIP ISSUE. WITHOUT THE PDM RETURNING FOR EVAL, WE ARE UNABLE TO CONCLUDE THAT AN ISSUE WITH THE BG METER MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE ERRORS. THE CUSTOMER HAD EXPERIENCED "VERY HIGH" BG LEVELS (HER BG WERE MEASURED TO BE 1,000MG/DL UPON ARRIVAL AT THE HOSPITAL). THEREFORE, IT IS POSSIBLE THE "CONTINUED" METER ERROR 2 ALERTS HAD RESULTED FROM "VERY HIGH BLOOD GLUCOSE (ABOVE 500MG/DL)" (THOUGH THIS CANNOT BE CONFIRMED). IN THE ABSENCE OF PDM AND TEST STRIP EVAL RESULTS, NO CONCLUSION CAN BE DRAWN. BY INITIATING THE METER ERROR 2 ALERTS TO WARN THE CUSTOMER OF A SERIOUS CONDITION, THE PDM HAD FUNCTIONED AS DESIGNED. CHAPTER 10, "ERRORS, ADVISORIES, AND HAZARD ALARMS" OF THE OMNIPOD USER GUIDE CONTAINS A SECTION DEDICATED TO THE POSSIBLE CAUSES OF METER ERROR 2 ALERTS AND THE ACTIONS TO BE TAKEN IF THIS ERROR IS ENCOUNTERED. A REVIEW OF LOT QUALIFICATION RECORDS WAS PERFORMED - THE LOT PASSED THE ACCEPTANCE CRITERIA. EVAL METHOD CODES ARE SPECIFIC TO ACTIVITIES PERFORMED DURING LOT QUALIFICATION, AND NOT TO ACTIVITIES PERFORMED ON THE SUBJECT PDM (AS IT WAS NOT RETURNED FOR EVAL).

    Description of Event or Problem · 1

    THE CUSTOMER'S HUSBAND REPORTED THAT HE WAS UNABLE TO CHECK HIS WIFE'S BG LEVELS DUE TO "CONTINUED" METER ERROR 2 ALERTS. " SEVERAL TEST STRIPS" WERE TRIED, BUT THE ERRORS PERSISTED. SHE WAS "BROUGHT TO THE HOSPITAL LAST NIGHT WITH A BG OF 1,000MG/DL." THE TREATMENT RECEIVED AT THE HOSPITAL AND HER LENGTH OF STAY WAS NOT PROVIDED. IT IS UNK WHETHER A BACK-UP METER WAS USED TO CHECK BG LEVELS WHEN THEY WERE UNABLE TO GET READINGS FROM THE PDM. THE DEVICE WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 13100-2B L50009

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention