BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAL PRDGM INS V2.2 CL EN

    MDR report key: 1092405 · Received August 1, 2008

    Report

    Report Number
    2032227-2008-01325
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    June 20, 2008
    Report Date
    July 18, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS AT THE HOSPITAL TO HAVE A PROCEDURE PERFORMED WHEN SHE WAS TAKEN TO THE EMERGENCY ROOM AS A RESULT OF HYPOGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 40 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. IT WAS FOUND THAT THE CUSTOMER HAD RECEIVED NUMEROUS NO DELIVERY AND MOTOR ERROR ALARMS ON THE INSULIN PUMP. THE CUSTOMER WAS TO REVERT TO A BACKUP PLAN UNTIL A REPLACEMENT INSULIN PUMP COULD BE DELIVERED TO HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAL PRDGM INS V2.2 CL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention