BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2802308 · Received October 23, 2012

    Report

    Report Number
    2531779-2012-12670
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    September 24, 2012
    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 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUBMITTED 12/15/2012 FOLLOW-UP # 1 - THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING RESULTS: MOISTURE INGRESS OBSERVED INSIDE THE DISPLAY SCREEN, A LEAK TEST WAS PERFORMED ON THE PUMP AND IT FAILED DUE A DISPLAY SCREEN LEAK. THE COVER OF THE PUMP WAS REMOVED FOR INTERNAL EXAMINATION, MOISTURE CORROSION WAS FOUND INSIDE ON THE POWER CIRCUIT AND ALL OVER THE PRINTED CIRCUIT BOARD. UNABLE TO TAKE THE AUDIBLE SOUND READING AS A RESULT OF POWER FAULT . PUMP'S DOWNLOAD ARE NOT AVAILABLE BY REASON OF MOISTURE DAMAGE TO THE UNIT. THE PUMP IS UNABLE TO POWER ON AND DISPLAY "VERIFY" SCREEN. UNABLE TO VERIFY ALL TESTING STEPS DUE TO POWER FAILURE.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS (ANM) ON BEHALF OF HER SON (THE PATIENT) ALLEGING THAT THE PUMP HAD AN INTERMITTENT POWER ISSUE. THE REPORTER DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE ALLEGED ISSUE. THE REPORTER CLAIMED THAT THERE WAS POSSIBLE EVIDENCE OF MOISTURE INGRESS WITH THE PUMP. SHE INDICATED THAT THE PATIENT HAD GONE SWIMMING WITH THE PUMP EARLIER THAT DAY. THE REPORTER DENIED THAT THERE WAS ANY DAMAGE TO THE KEYPAD OR PUMP'S CASING. SHE WAS ABLE TO SECURE THE BATTERY CAP TO THE PUMP. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE PUMP WAS REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PUMP HAD A POWER ISSUE THAT WAS NOT RESOLVED WITH TROUBLESHOOTING. SHE ALSO CLAIMED THAT THE PUMP HAD EVIDENCE OF MOISTURE INGRESS WITH NO VISIBLE PUMP DAMAGE. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY SYMPTOMS, TREATMENT, OR BLOOD GLUCOSE VALUES SUGGESTIVE OF A SERIOUS INJURY.

    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 8 YR