BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4141564 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-32871
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP PASSED THE PRIME, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS. ALL THE BUTTONS DID FUNCTION PROPERLY. NO BUTTON ERROR ALARMS NOTED. HOWEVER MOISTURE DAMAGE WAS NOTED ON THE KEYPAD TRACES. CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION.

    Additional Manufacturer Narrative · 1

    (B)(4).CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT DELIVERING INSULIN. SHE STATED THAT THE BLOOD GLUCOSE CONTINUED TO RISE AND SHE RESORTED TO TREATING WITH MANUAL INJECTIONS. THE BLOOD GLUCOSE READING WAS 500 MG/DL. SHE STATED THAT THE BASAL RATE AND BOLUS WIZARD SETTINGS WERE CORRECT. SHE REPORTED THAT SHE HAD ALSO RECEIVED A BUTTON ERROR ALARM BUT DID NOT RECALL ANY SIGNIFICANT EVENT LEADING TO THAT ISSUE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621241 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention