BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3101913 · Received May 9, 2013

    Report

    Report Number
    2531779-2013-06067
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 07/12/2013- DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY REVEALED POWER ON RESETS. NO DAMAGE WAS FOUND TO THE BATTERY CAP OR COMPARTMENT. THE BATTERY CAP CONTACT WAS FOUND TO BE WITHIN SPECIFICATIONS; THE CAP ATTACHED SECURELY TO THE PUMP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER INTERRUPTIONS OCCURRING. THE PUMP WAS OPENED AND NO INTERNAL MOISTURE/ DAMAGE WAS FOUND TO THE POWER CIRCUIT OR BATTERY FLEX. THE POWER ISSUE WAS VERIFIED IN HISTORY BUT NOT DUPLICATED DURING TESTING. THIS MEDWATCH SUBMISSION WAS ORIGINALLY TRANSMITTED ON (B)(4) 2013, BUT THE SUBMISSION WAS UNABLE TO BE ACCEPTED DUE TO A NETWORK FILE SYSTEM ISSUE IN THE FDA ELECTRONIC SUBMISSIONS GATEWAY (ESG) PRODUCTION SYSTEM. THE FDA ESG TEAM HAS REQUESTED THAT THIS SUBMISSION BE RE-TRANSMITTED. THE SUBMISSION DATE FOR THIS REPORT IS (B)(4) 2013 AND THE SUBMISSION WILL NOT BE CONSIDERED LATE.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING ELEVATED BLOOD GLUCOSE (BG) OVER THE PAST SEVERAL DAYS; THE REPORTED BG MEASUREMENT WAS 297 MG/DL WITHOUT REPORTED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA. THIS REPORTED BG ELEVATION DOES NOT MEET ANIMAS' CRITERIA OF A REPORTABLE ADVERSE EVENT. AT THE TIME OF THE CALL, THE PATIENT REPORTED HER BG AS 157 MG/DL. THE PATIENT REPORTED THAT THE PUMP WAS POWERING OFF RANDOMLY FOR THE PAST THREE DAYS. THE PATIENT STATED THAT PRIOR TO POWERING OFF, THE PUMP MAKES A NOISE AS IF IT IS REBOOTING. THE PATIENT REPORTED THE BATTERY CAP IS SECURE ON THE PUMP. THE PATIENT DENIED PHYSICAL DAMAGE TO BATTERY COMPARTMENT OR BATTERY CAP. THE PATIENT DENIED MOISTURE OR CORROSION IN THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PUMP MALFUNCTION REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202923 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR