BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3231857 · Received July 11, 2013

    Report

    Report Number
    3004464228-2013-00745
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 13, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION COULD HAVE CONTRIBUTED TO THE PT'S REPORTED HOSPITALIZATION FOR HYPOGLYCEMIA. NO LOT QUALIFICATION RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. THE OMNIPOD USER GUIDE WARNS, "'LOW' OR 'HIGH' BLOOD GLUCOSE READINGS CAN INDICATE A POTENTIALLY SERIOUS CONDITION REQUIRING IMMEDIATE MEDICAL ATTENTION. IF LEFT UNTREATED, THIS SITUATION CAN QUICKLY LEAD TO DIABETIC KETOACIDOSIS (DKA), SHOCK, COMA, OR DEATH. IF YOUR READING IS BELOW 20 MG/DL, THE PDM DISPLAYS: 'LOW TREAT YOUR LOW BLOOD GLUCOSE!' THIS INDICATES SEVERE HYPOGLYCEMIA (LOW BLOOD GLUCOSE). IF YOU GET A 'LOW TREAT YOUR LOW BLOOD GLUCOSE!' READING AND FEEL SYMPTOMS SUCH AS WEAKNESS, SWEATING, NERVOUSNESS, HEADACHE, OR CONFUSION, FOLLOW YOUR HEALTHCARE PROVIDER'S RECOMMENDATION TO TREAT HYPOGLYCEMIA. IF YOU GET A 'LOW TREAT YOUR LOW BLOOD GLUCOSE!' READING, BUT HAVE NO SYMPTOMS OF LOW BLOOD GLUCOSE, THEN RETEST WITH A NEW TEST STRIP ON YOUR FINGERS. IF YOU STILL GET A 'LOW TREAT YOUR LOW BLOOD GLUCOSE!' READING, PERFORM A CONTROL SOLUTION TEST TO ENSURE YOUR SYSTEM IS WORKING PROPERLY. IF THE SYSTEM IS WORKING PROPERLY, FOLLOW YOUR HEALTHCARE PROVIDER'S RECOMMENDATION TO TREAT HYPOGLYCEMIA." IT ADVISES, "HYPOGLYCEMIA CAN OCCUR EVEN WHEN A POD IS WORKING PROPERLY. NEVER IGNORE THE SIGNS OF LOW BLOOD GLUCOSE (NO MATER HOW MILD). IF LEFT UNTREATED, SEVERE HYPOGLYCEMIA CAN CAUSE SEIZURES OR LEAD TO UNCONSCIOUSNESS. IF YOU SUSPECT THAT YOUR BLOOD GLUCOSE LEVEL IS LOW, CHECK YOUR BLOOD GLUCOSE LEVEL TO CONFIRM" AND "TO TREAT HYPOGLYCEMIA (LOW BLOOD GLUCOSE): ANY TIME YOUR BLOOD GLUCOSE IS LOW, TREAT IT IMMEDIATELY. CHECK IF EVERY 15 MINUTES WHILE YOU ARE TREATING, TO MAKE SURE YOU DON'T OVERTREAT THE CONDITION AND CAUSE BLOOD GLUCOSE LEVELS TO RISE TOO HIGH."

    Description of Event or Problem · 1

    AN INSULET CLINICAL SERVICE MANAGER REPORTED THAT A PT WAS ON HER WAY TO THE HOSPITAL WITH LOW BLOOD GLUCOSE LEVELS. IN A FOLLOW-UP CALL TO THE PT, THE PT REPORTED THAT SHE HAD BEEN ADMITTED FOR HYPOGLYCEMIA. SHE SAID THAT HER RESULT WAS "LOW" (<20 MG/DL) ON THE PDM. SHE SAID THAT SHE WAS GIVEN GLUCAGON IN THE HOSPITAL. SHE STATED THAT SHE WAS NOT HAVING AN ISSUE WITH THE SYSTEM; THERE WERE SETTING ADJUSTMENTS THAT NEEDED TO BE MADE ON THE PDM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321221 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization