BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3113549 · Received May 15, 2013

    Report

    Report Number
    2531779-2013-06443
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT THE PUMP WAS SUSPENDED ON (B)(6) 2007 AT 2:24 AM AND RESUMED AT 4:17 AM. A SUSPEND ALSO OCCURRED ON (B)(6) 2007 AT 7:14 AM AND RESUMED AT 8:24 AM. A 1 UNIT PER HOUR BASAL PROGRAM WAS EXECUTED ON THE PUMP FOR A 24 HOUR DURATION PERIOD; NO SELF SUSPENDING OCCURRED DURING THIS TIME PERIOD. NO HYPERSENSITIVE KEYS WERE OBSERVED ON KEYPAD. A (B)(4) FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. THE REPORTED COMPLAINT WAS UNABLE TO BE DUPLICATED.

    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.

    Description of Event or Problem · 1

    PATIENT'S MOM CALLED IN AND STATED THAT SHE IS HAVING ISSUES WITH THE PUMP SUSPENDING, AND THAT ON AND OFF FOR THE LAST WEEK THE BLOOD GLUCOSE (BG) HAS BEEN IN THE 500 MG/DL RANGE OFF RELATED TO THIS ISSUE. MOM STATES THEY ALWAYS CHANGE HER SITE FIRST AND THERE IS NO ISSUE FOUND, STATED THAT THEY GIVE BOLUS VIA INJECTION AND TEST FOR KETONES (NEGATIVE) , ALSO STATED THAT BG DOES SLOWLY RETURN TO TARGET RANGE. NO DELIVERY, NO ALARMS IN THE HISTORY AND STATED THAT WHEN SHE CHECKS THE SETTING IN THE SUSPEND MENU THAT IT IS SAYING SUSPEND AND NOT RESUME AND IS UNABLE TO DETERMINE WHAT THE SUSPEND IS RELATED TO. CUSTOMER TECHNICAL SUPPORT (CTS) FOUND N O ALARMS NOTED OTHER THEN LOW BATTERY AND REPLACE BATTERY, NO SUSPENDS WITHIN MINUTES OF EACH OTHER AND THERE ARE NO ALARMS IN THE HISTORY RELATED TO THE ISSUE. PATIENT IS CURRENTLY GOING TO BACKUP PLAN AND IS NOT HAVING A CURRENTLY HAVING AN ISSUE WITH BG. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PUMP IS SUSPENDING ITSELF WITHOUT USER INTERVENTION AND THE PATIENT HAS EXPERIENCED HYPERGLYCEMIA RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214305 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening