BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3081808 · Received April 29, 2013

    Report

    Report Number
    2531779-2013-05455
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    March 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(4) 2013- DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE FULLY INTACT; NO PEELING OR DAMAGE WAS OBSERVED. DURING TESTING, THE DOWN ARROW AND OK KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY UNRESPONSIVE. THE UP ARROW BUTTON WAS FOUND TO BE HYPERSENSITIVE AND CAUSED SCROLLING. THE CONTRAST BUTTON WAS RESPONSIVE. DURING INVESTIGATION, THE KEYPAD WAS REMOVED AND EVIDENCE OF CONTAMINATION WAS FOUND UNDER THE UP ARROW, OK, AND CONTRAST KEY CONTACTS. THE UP ARROW KEY CONTACT WAS FOUND TO BE MISALIGNED. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE DISCOLORED. A TEST SCREEN WAS INSERTED AND FUNCTIONED APPROPRIATELY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS TO REPORT THAT MULTIPLE BUTTONS ON THE KEYPAD OF THE PUMP ARE INTERMITTENTLY UNRESPONSIVE OR DELAYED IN ACTION. IT WAS ALLEGED THAT THE BUTTONS SOMETIMES CAUSE SCROLLING ACTION. THE PATIENT REPORTED THAT HE NOTICED LAST NIGHT WHILE TRYING TO DELIVER A BOLUS AND WAS UNABLE TO PROGRAM THE PUMP TO THE CORRECT UNITS AND THEN PRESSED THE OKAY BUTTON MULTIPLE TIMES TO ACHIEVE THE DESIRED RESPONSE. ALLEGEDLY DUE TO THE DELAY IN BOLUS DELIVERY, THE PATIENT STATED THAT BLOOD GLUCOSE (BG) WAS 500MG/DL WITHOUT SYMPTOMS OF HYPERGLYCEMIA. THE PATIENT SAID THAT BG WAS CORRECTED VIA BOLUS FROM THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE OF THE KEYPAD BUTTONS REMAINED UNRESOLVED AND THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA DUE TO THE DELAYED BUTTON RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184643 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening