BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2993349 · Received March 7, 2013

    Report

    Report Number
    2032227-2013-00929
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    December 15, 2012
    Report Date
    February 21, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR. UNABLE TO PERFORM BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY TEST DUE TO PRIME/FILL ANOMALY. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. THE INSULIN PUMP HAD A CRACK AROUND BATTERY TUBE THREADS AND STRIPPED COIN SLOT BATTERY CAP.

    Additional Manufacturer Narrative · 1

    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

    THE CUSTOMER REPORTED THAT SHE WAS UNABLE TO REMOVE THE BATTERY CAP DUE TO A CRACKED CASE. THE CUSTOMER STATED THAT THE PARAMEDICS WERE CALLED DUE TO SEIZURES SHE WAS EXPERIENCING, AND THEY HAD TO HOLD HER DOWN. THE CUSTOMER STATED THAT THIS IS HOW THE DAMAGE WAS CAUSED TO THE CASE. UNKNOWN WHETHER OR NOT THE SEIZURES WERE DIABETES RELATED. THE CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 487 MG/DL, AND HAD BEEN TREATED. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED DUE TO THE DAMAGE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97441 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention