BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2083618 · Received May 10, 2011

    Report

    Report Number
    2531779-2011-03313
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 10, 2011
    Report Date
    April 10, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: PUMP BOOTED TO 'VERIFY' SCREEN WITH FUNCTIONAL AUDITORY AND VIBRATORY ALARMS. THE PUMP BLACKBOX HISTORY SHOWS THAT THE PUMP REBOOTED MULTIPLE TIMES IN A CYCLE ON (B)(6) 2011. NO POWER LOSS ISSUES WERE REPRODUCED DURING INVESTIGATION. THE BATTERY CAP AND BATTERY COMPARTMENT WERE INTACT. THE BATTERY CAP ABLE TO SECURELY FASTEN TO THE PUMP WITH NO VISIBLE YELLOW O-RING.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. THE EVALUATION OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE REPORTER CONTACTED ANIMAS ON BEHALF OF HIS SON (THE PATIENT) ALLEGING THAT THE PUMP WAS REBOOTING. THE REPORTER REPORTED A BLOOD GLUCOSE LEVEL OF "285 MG/DL" BUT DENIED THAT THE PATIENT HAD ANY SYMPTOMS OF THIRST OR FREQUENT URINATION. THE PATIENT WAS NOT TESTED FOR KETONES. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PUMP WAS REBOOTING. THERE IS NO EVIDENCE HOWEVER THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE REPORTER DID NOT REPORT ANY BLOOD GLUCOSE VALUES OR SYMPTOMS THAT MEET ANIMAS' CRITERIA FOR 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 12 YR