BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2160032 · Received July 13, 2011

    Report

    Report Number
    2531779-2011-04889
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THE KEYPAD WAS TORN NEXT TO THE UP ARROW KEYPAD BUTTON. A DAMAGED KEYPAD WILL PERMIT CONTAMINATION TO PERMEATE THE BUTTONS WHICH WILL HAVE A NEGATIVE IMPACT ON BUTTON FUNCTION. THIS SITUATION IS NOT LIKELY TO RESULT IN AN ADVERSE EVENT AS THE DAMAGED KEYPAD SHOULD BE CLEARLY VISIBLE AND WARNS THE PATIENT TO DISCONTINUE USING THE PUMP. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED. EVALUATION REVEALED THAT THE OK KEYPAD BUTTON IS INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE REPORTER CONTACTED ANIMAS ON BEHALF OF HER SON (THE PATIENT) ALLEGING THAT KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE REPORTER DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PUMP WAS UNRESPONSIVE TO BUTTON PRESSES. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE REPORTER DID NOT REPORT ANY SYMPTOMS, BLOOD GLUCOSE VALUES, OR TREATMENT SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR