BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2180459 · Received July 27, 2011

    Report

    Report Number
    2531779-2011-05335
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #2 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. REVIEW OF THE ACCESSIBLE BLACK BOX AND ALARM HISTORY SHOWS NO ERRORS OR ALARMS ASSOCIATED WITH THE COMPLAINT. THE TOTAL DAILY INSULIN DELIVERIES ADD UP CORRECTLY AND REFLECT THE USER'S PROGRAMMED BASAL RATES. THE RETURNED PUMP WAS SUBJECT TO A 29 HOUR FLOW ACCURACY TEST; THE PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFIED RANGE.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER/REPORTER CLAIMED THAT THE PATIENT HAS BEEN USING THE ANIMAS PUMP TO MANAGE HIS DIABETES FOR THE (B)(6). REPORTEDLY, THE PATIENT'S HAS NOT BEEN ABLE TO LOWER HIS BLOOD GLUCOSE AS HIS BLOOD GLUCOSE RANGED FROM 220-499 MG/DL. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS THAT WOULD SUGGEST HYPERGLYCEMIA OR HYPERGLYCEMIA. THE REPORTER STATED THE PATIENT'S BLOOD GLUCOSE FINALLY RESPONDED WHEN A CORRECTION INSULIN DOSE WAS GIVEN VIA A SYRINGE. DURING TROUBLESHOOTING, THE REPORTER REVEALED THAT THE PATIENT'S SITE WHERE THE INSULIN WAS DISPENSED WAS CHANGED 3 TIMES. TWO OUT OF THE 3 TIMES, A BENT CANNULA ISSUE WERE DISCOVERED. THE ANIMAS PUMP REPORTEDLY IS PROGRAMMED WITH THE CORRECT DATE AND TIME, BASAL SEGMENT, AND ADVANCE FEATURES. THERE WAS NO PRODUCT MISUSE. THE REPORTER CLAIMED THAT WAS AIR BUBBLES IN THE CARTRIDGE THE DAY BEFORE. THE PEN FILLED INSULIN WAS OPENED FOR (B)(6). BASED ON THE ANIMAS HEALTHCARE PROVIDER'S ANALYSIS, THE PATIENT'S ALLEGED HYPERGLYCEMIA MAY BE ATTRIBUTED TO USER ERROR AS THERE WAS EVIDENCE OF BENT CANNULA, AIR BUBBLES IN THE CARTRIDGE, AND USAGE OF INSULIN OPENED (B)(6). THERE WAS NO EVIDENCE THAT THE SUBJECT PUMP HAD MALFUNCTIONED. THE PUMP WILL NOT BE RETURNED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY HAD ELEVATED READING FOR (B)(6) DUE TO POSSIBLE USER ERROR.

    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 Life Threatening