BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2830231 · Received November 13, 2012

    Report

    Report Number
    2531779-2012-13517
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY-USER/PATIENT CONTACTED ANIMAS (ANM) ALLEGING THAT KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. SHE ALSO ALLEGED THAT FOR THE PAST FEW MONTHS, BOLUSES WERE BEING CANCELED. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE. THE PATIENT CLAIMED THAT THE PUMP HAD BEEN INTERMITTENTLY UNRESPONSIVE TO KEYPAD BUTTON PRESSES SINCE LAST SPRING. SHE INDICATED THAT SHE WOULD HAVE TO PRESS THE BUTTONS HARDER AND SEVERAL TIMES BEFORE THE PUMP WOULD RESPOND. THE PATIENT WAS UNABLE TO RECALL WHAT HER BG LEVEL WAS AND IF SHE HAD DEVELOPED ANY SYMPTOMS OF HYPERGLYCEMIA THE LAST TIME A BOLUS WAS CANCELED. SHE ONLY REMEMBERED NOT FEELING GOOD AND ALSO NOTICED THAT A BOLUS HAD BEEN CANCELED. THE PATIENT DENIED HAVING ANY OTHER HEALTH CONDITIONS OR MEDICATIONS. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE PATIENT DENIED THAT THE PUMP EVER GOT WET OR THAT THE DEVICE SUFFERED ANY TRAUMA. THE PUMP WAS REPLACED. THE ANM REPRESENTATIVE INVOLVED IN THIS CONTACT INFORMED THE PATIENT THAT THE PUMP WAS NOT SAFE TO USE DUE TO THE ALLEGED KEYPAD ISSUE. SHE WAS ADVISED TO GO ON A BACKUP PLAN FOR INSULIN DELIVERY. THE PUMP WAS OUT OF WARRANTY. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT THE PUMP WAS UNRESPONSIVE TO KEYPAD BUTTON PRESSES. THERE IS NO EVIDENCE HOWEVER THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY BLOOD GLUCOSE VALUES, SYMPTOMS, OR TREATMENT SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR