BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2210990 · Received August 13, 2011

    Report

    Report Number
    2531779-2011-05862
    Event Type
    Malfunction
    Date Received
    August 13, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 17, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE 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

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP POWERS ON WITH FUNCTIONAL AUDITORY AND VIBRATORY ALARMS. THERE WAS NO EVIDENCE OF POWER LOSS OBSERVED IN THE PUMP HISTORY. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT INTERRUPTIONS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A CRACKED DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. 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 REPORTED THAT SHE NOTICED THE PUMP HAD NO POWER WHEN ATTEMPTING TO BOLUS. SHE CONFIRMED THAT THE SCREEN WAS BLANK AND THERE WERE NO AUDIBLE TONES. SHE STATED THAT SHE CHANGED THE BATTERY, AND THE PUMP STILL DID NOT HAVE POWER. THE PATIENT DID NOT RECALL RECEIVING A REPLACE BATTERY ALARM OR LOW BATTERY WARNING. SHE STATED THAT THE LAST BATTERY CHANGE WAS A WEEK PRIOR TO THE INCIDENT, AND THE BATTERY CAP WAS CHANGED TWO MONTHS PRIOR TO THE INCIDENT. THE PATIENT CONFIRMED THAT THERE WAS NO VISIBLE CORROSION IN THE BATTERY COMPARTMENT AND NO STRUCTURAL DAMAGE TO THE BATTERY CAP AND COMPARTMENT. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    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 30 YR