BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3840618 · Received May 30, 2014

    Report

    Report Number
    2531779-2014-15245
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #2 SUBMITTED 07/31/2014: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING RESULTS: UNABLE TO DUPLICATE THE COMPLAINT, INFORMATION FOR THE COMPLAINT IS OVERWRITTEN. THE BLACK BOX BEGINS ON (B)(6) 2014. THE BLACK BOX INFORMATION FOR THE EVENT ON (B)(6) 2014 IS OVERWRITTEN; UNABLE TO DETERMINE IF A POWER EVENT OCCURRED ON THE EVENT DATE. NO OTHER POR¿S OBSERVED IN CURRENT BLACK BOX NO DAMAGE FOUND TO RETURNED BATTERY CAP. BATTERY COMPARTMENT IS CRACKED UNDER THE BUMPER GRIP. RETURNED BATTERY CAP WAS ABLE TO FULLY TIGHTEN TO THE PUMP WITH NO YELLOW O RING SHOWING. PUMP WAS EXERCISED FOR 24HRS WITH RETURNED BATTERY CAP, NO POWER INTERRUPTIONS WERE DUPLICATED. THE RETURNED BATTERY CAP CONTACT MEASUREMENTS ARE IN SPECIFICATION. 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

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. (B)(6).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 05/27/2014: REPORTER CALLED BACK AND CLARIFIED THAT WHEN PATIENT GOT TO SCHOOL ON THURSDAY, (B)(6) 2014, SHE WENT TO BOLUS AND REALIZED HER PUMP WAS NOT ON, IT WAS OFF/BLANK, NOTHING HAPPENING. PATIENT WENT TO NURSE'S OFFICE AND CHANGED BATTERY, PUMP TURNED ON. THIS WAS THE FIRST TIME THIS HAS OCCURRED. PATIENT DOES NOT BELIEVE YELLOW O-RING ON BATTERY CAP WAS VISIBLE AT TIME OF EVENT. NO DAMAGE TO BATTERY CAP, NO DAMAGE TO PUMP, NO MOISTURE/CORROSION. ALWAYS USES LITHIUM BATTERY. PATIENT FELT SICK DUE TO BG, WHICH READ HI ON METER. BOLUS WAS GIVEN AT SCHOOL TO TREAT FOR BG AND REPORTER CONTINUED TO MONITOR PATIENT THE REST OF THE DAY, DID NOT NEED TO SEEK MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE PUMP HAD A POWER ISSUE AND THAT THE PATIENT HAD A BLOOD GLUCOSE >500 MG/DL WITH MODERATE KETONES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA AND THE POWER ISSUE WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319610 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening