BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2210935 · Received August 12, 2011

    Report

    Report Number
    2531779-2011-05861
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Report Date
    July 16, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 09/14/2011 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP POWERS ON TO THE VERIFICATION SCREEN WITH FUNCTIONAL AUDITORY AND VIBRATORY ALARMS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO INTERRUPTIONS. A REVIEW OF THE PUMP HISTORY INDICATED THAT AN EMPTY CARTRIDGE ALARM OCCURRED ON (B)(6) 2011 AT 5:52, AND WAS NOT CONFIRMED UNTIL (B)(6) 2011 AT 8:08. DUE TO THE UNCONFIRMED ALARM, THE BATTERY POWER WAS DRAINED AND THE PUMP ENTERED A REBOOTING CYCLE. THE PUMP HISTORY INDICATED THAT THE PATIENT INSERTED A DISCHARGED BATTERY WHEN PERFORMING A BATTERY CHANGE. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THAT THE KEYPAD WAS TORN AT 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.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED THAT THE ANIMAS PUMP WILL NOT POWER ON AFTER THE BATTERY WAS REPLACED. THERE WAS NO PRODUCT MISUSE. THE BATTERY CAP AND COMPARTMENT WAS NOT DAMAGED. THE BATTERY COMPARTMENT WAS CORROSION FREE. THE ISSUE WAS NOT RESOLVED WITH TRAINING. THE PRODUCT WAS SENT BACK FOR INVESTIGATION. THE PATIENT WAS ADVISED TO GO ON THE BACKUP PLAN. THERE WAS NO REPORT OF ANY PATIENT IMPACT ASSOCIATED WITH THE COMPLAINT. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE POWER ISSUE.

    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 29 YR