BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4181268 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39513
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, A CRACKED RESERVOIR TUBE LIP, AND MINOR SCRATCHES ON THE DISPLAY WINDOW. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST AND EXCESSIVE NO DELIVERY ALARM TEST. THE INSULIN PUMP COMMUNICATED PROPERLY TO THE TEST TRANSMITTER. NO SENSOR ANOMALY OR BLOOD GLUCOSE READING ANOMALY WAS NOTED.

    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. PLEASE SEE MEDWATCH REPORT # 2032227-2014-39018.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS AND THAT THE INSULIN PUMP HAD SCRATCHES ON THE SCREEN WHICH SOMETIMES MADE THE DISPLAY ILLEGIBLE. THE CUSTOMER ALSO REPORTED SOME TROUBLES WITH HER SENSOR. THE BLOOD GLUCOSE READING WAS OVER 500 MG/DL SINCE IT HAD SHOT UP VERY QUICKLY IN ABOUT AN HOUR'S TIME. THE MOST RECENT BLOOD GLUCOSE READING WAS 260 MG/DL AFTER THE CUSTOMER HAD TREATED WITH THE INSULIN PUMP. SHE DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE, STATING THAT SHE ALWAYS HAS HIGH BLOOD GLUCOSE AND WAS NEVER NORMAL. SHE STATED THAT, FOR THE MOST PART, SHE WAS ABLE TO READ THE DEVICE SCREEN AS LONG AS SHE HIT IT AT A RIGHT ANGLE. SHE NOTED THAT THE DEVICE WAS FUNCTIONING AS DESIGNED OTHERWISE. ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660411 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR