BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2232285 · Received September 2, 2011

    Report

    Report Number
    2531779-2011-06429
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    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. THE PATIENT REPORTED HAVING SOME ISSUES WITH MEMORY WHICH MAY HAVE CAUSED HER TO MISS BOLUSES AND BLOOD GLUCOSE TESTS. NO CONCLUSIONS CAN BE MADE AT THIS TIME; THIS USE ERROR MAY HAVE CONTRIBUTED TO THE PATIENT'S BLOOD GLUCOSE EXCURSION.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE PUMP HISTORIES SHOW DATA FROM (B)(6) 2012. THE DATE OF THE REPORTED EVENT WAS (B)(6) 2011. THE DATA FROM THE TIME OF THE REPORTED EVENT IS UNAVAILABLE FOR REVIEW DUE TO CONTINUED PUMP USE. A REVIEW OF THE AVAILABLE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THAT THE KEYPAD IS TORN AT THE OK AND DOWN ARROW KEYPAD BUTTONS. 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 UP ARROW, DOWN ARROW, AND CONTRAST KEYPAD BUTTONS ARE INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER ALL KEY CONTACTS. EVALUATION ALSO REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT WAS HOSPITALIZED ON (B)(6) 2011 WITH HIGH BLOOD GLUCOSE (BG). THE PATIENT WAS REPORTEDLY TREATED WITH INSULIN INJECTIONS AND INTRAVENOUS FLUIDS. THE PATIENT STATED THAT HER BLOOD GLUCOSE WAS OVER 500 MG/DL FOR SEVERAL DAYS PRIOR TO SEEKING TREATMENT. THE PATIENT REPORTED THAT SHE HAD CHANGED THE INFUSION SETS MULTIPLE TIMES AND HER BG DID NOT RESPOND. THE PATIENT CONFIRMED THAT THE HISTORY AND SETTINGS WERE CORRECT IN THE PUMP. THE PATIENT REPORTED THAT THERE HAVE BEEN NO SIGNS OF SITE ISSUES. THE PATIENT REPORTED THAT SHE WAS HAVING SOME ISSUES WITH HER MEMORY DUE TO OTHER MEDICATIONS SHE WAS TAKING AND THIS MAY HAVE LED TO FORGETTING TO BOLUS OR TEST BG. CUSTOMER SUPPORT CONCLUDED THAT THERE WAS NO INDICATION A MECHANICAL PROBLEM WITH THE PATIENT'S PUMP OR SUPPLIES. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    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 48 YR Hospitalization