BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3972231 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88643
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED FOR A MOTOR ERROR DURING THE BASIC OCCLUSION TEST AND ALARMED DURING THE PRIME TEST DUE TO A FAULTY TIN FORCE SENSOR RESISTOR. THE MOTOR PASSED THE MOTOR TEST. THE OCCLUSION TEST COULD NOT BE PERFORMED DUE TO A MOTOR ERROR ALARM. NO COSMETIC DAMAGE WAS NOTED.

    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

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS AND THAT THE INSULIN PUMP ALARMED MOTOR ERROR AND ANOTHER ERROR DURING PRIMING PROCESS. THE BLOOD GLUCOSE READING WAS 465 MG/DL, WHICH THE CUSTOMER TREATED WITH 6 UNITS OF INSULIN VIA MANUAL INJECTION. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE LEVELS ARE HIGH BECAUSE SHE WAS NOT RECEIVING THE INSULIN. SHE COMPLAINED OF SLUGGISHNESS AND LACK OF ENERGY AS SYMPTOMS OF HIGH BLOOD GLUCOSE. THE DEVICE HAD NOT BEEN BUMPED NOR DROPPED PRIOR TO THE ALARM. UPON TROUBLESHOOTING, IT WAS FOUND THAT THE CUSTOMER COULD NOT CHECK THE DEVICE'S ALARM HISTORY DUE TO THE OTHER ERRORS. ADVISED THE DISCONTINUATION AND REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447542 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention