BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2113394 · Received June 3, 2011

    Report

    Report Number
    2531779-2011-03909
    Event Type
    Injury
    Date Received
    June 3, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1, DATE OF SUBMISSION (B)(6) 2011 - DEVICE EVALUATION: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. ALL KEYPAD BUTTON RESPOND TO PRESSES APPROPRIATELY DURING TESTING. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS.

    Additional Manufacturer Narrative · 1

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

    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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/REPORTER CONTACTED ANIMAS ON BEHALF OF HER GRANDDAUGHTER (THE PATIENT) ALLEGING THAT BOLUSES WERE BEING CANCELLED WITHOUT USER INTERVENTION WITH A PUMP. THE REPORTER CLAIMED THAT BOLUSES WERE CANCELLED ON (B)(6) 2011, (B)(6) 2011, AND (B)(6) 2011. THE PATIENT DENIED THAT SHE CANCELLED THE BOLUSES. THE REPORTER INDICATED THAT ON (B)(6) 11, THE PATIENT'S BLOOD GLUCOSE (BG) LEVEL WAS 412 MG/DL. LATER THAT SAME DAY, THE PATIENT'S BG LEVEL ALLEGEDLY REACHED 540 MG/DL WITH NO SYMPTOMS. THE PATIENT REPORTEDLY TREATED THE ELEVATED BG WITH THE PUMP. THE PATIENT'S BG DECREASED TO 150 MG/DL. ALSO, ON (B)(6) 2011, THE PATIENT'S BG WAS 400 MG/DL IN THE MORNING. SHE REPORTEDLY BOLUSED AND HER BG CAME DOWN TO 260 MG/DL AND THEN 180 MG/DL. DURING THE TIME OF CONCERN, THE PATIENT ALLEGEDLY HAD POSITIVE KETONES AND NAUSEA. THE REPORTER DENIED THAT THE PATIENT HAD VOMITING OR SHORTNESS OF BREATH. THE PUMP'S DATE/TIME WERE CORRECT. ALL BASAL INSULIN WAS DELIVERED AS PROGRAMMED FOR (B)(6) 2011. NO LEAKAGE WAS NOTED AT THE SITE. THE PUMPS I:C, ISF AND TARGET, AND IOB WERE CORRECT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER ALLEGED THAT PUMP WAS CANCELLING BOLUSES WITHOUT USER INTERVENTION AND THE PATIENT DEVELOPED A BLOOD GLUCOSE LEVEL AND 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 16 YR Life Threatening