BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2974087 · Received February 13, 2013

    Report

    Report Number
    3004464228-2013-00117
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 6, 2013
    Report Date
    January 14, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION FOR DKA AND HEART ATTACK. NO LOT QUALIFICATION RECORDS WERE REVIEWED, AS A PRODUCT LOT NUMBER WAS NOT REPORTED. THE OMNIPOD USER GUIDE WARNS, "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPERGLYCEMIA, REPEAT TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER." IT ADVISES, "THE EASIEST AND MOST RELIABLE WAY TO AVOID DKA IS BY CHECKING YOUR BLOOD GLUCOSE AT LEAST 4-6 TIMES A DAY. ROUTINE CHECKS ALLOW YOU TO IDENTIFY AND TREAT HIGH BLOOD GLUCOSE BEFORE DKA DEVELOPS. ONCE YOU HAVE BEGUN TREATMENT FOR HIGH BLOOD GLUCOSE, CHECK FOR KETONES. CHECK FOR KETONES ANY TIME YOUR BLOOD GLUCOSE IS 250 MG/DL OR ABOVE. IF KETONES ARE NEGATIVE OR TRACE, CONTINUES TREATING FOR HIGH BLOOD GLUCOSE. IF KETONES ARE PRESENT, AND YOU ARE FEELING NAUSEATED OR ILL, IMMEDIATELY CALL YOUR HEALTHCARE PROVIDER FOR GUIDANCE. IF KETONES ARE POSITIVE, BUT YOU ARE NOT FEELING NAUSEATED OR ILL, REPLACE THE POD, USING A NEW VIAL OF INSULIN. CHECK BLOOD GLUCOSE AGAIN AFTER 2 HOURS. IF BLOOD GLUCOSE LEVEL HAS NOT DECLINED, IMMEDIATELY CALL YOUR HEALTHCARE PROVIDER FOR GUIDANCE."

    Description of Event or Problem · 1

    THE CUSTOMER'S DAUGHTER STATED THAT HER MOTHER'S BLOOD GLUCOSE WAS 298 MG/DL AT 9:18AM. THERE WERE NO BLOOD GLUCOSE READINGS TAKEN UNTIL 10:33PM, WHEN IT WAS 262 MG/DL. AT 11:27PM, HER BLOOD GLUCOSE WAS 340 MG/DL, AND SHE CORRECTED WITH A 3.8 UNIT BOLUS. WHEN HER MOTHER DID NOT SHOW UP AT WORK, HER DAUGHTER CHECKED ON HER AND FOUND HER COLLAPSED ON THE FLOOR. SHE WAS THEN TAKEN TO THE HOSPITAL WHERE SHE WAS IN DKA AND SUFFERED A HEART ATTACK. HER KETONES WERE HIGH AND HER A1C WAS AT 11.4. HER DAUGHTER WAS UNABLE TO CONFIRM THE TREATMENT FOR THE HEART ATTACK, BUT STATED THAT SHE WAS GIVEN AN INSULIN DRIP AND MOVED INTO INTENSIVE CARE. THE CUSTOMER DID NOT WAKE UP FOR ABOUT A WEEK AFTER THE INCIDENT. AFTER SHE AWOKE,SHE WAS MOVED OUT OF INTENSIVE CARE. HER DAUGHTER ALSO STATED THAT HER MOTHER'S EYE PRESSURE HAS "RAISED WITH EVERY ENCOUNTER," AS SHE HAS BEEN HOSPITALIZED TWICE. THE POD SHE WAS WEARING WAS NOT RETURNED, AS IT WAS REMOVED AND DISPOSED OF AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64325 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization