BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3213802 · Received July 9, 2013

    Report

    Report Number
    2531779-2013-10034
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 08/06/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX CONTAINS DATES FROM (B)(6) 2014. THE BLACK BOX AND HISTORIES FOR THE EVENT ON (B)(6) 2013 HAVE BEEN OVERWRITTEN. AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. 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 FOR EVALUATION. 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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT¿S FIANCÉE/REPORTER CONTACTED ANIMAS TO REPORT THE PATIENT HAD A BLOOD GLUCOSE READING OF 40 MG/DL WHILE SHE HAD A NO PRIME ALARM ISSUE. REPORTEDLY, THE SUBJECT PUMP WAS NOT RECEIVING ANY BASAL INSULIN DUE TO THE AUTO OFF FEATURE SINCE 8:30 AM. THE PATIENT¿S LOW BLOOD GLUCOSE READING OCCURRED AT 9 AM. THE PATIENT ALLEGEDLY SUFFERS FROM HYPOGLYCEMIA UNAWARENESS AND DID NOT HAVE ANY SYMPTOMS AT THE TIME OF CONCERN. THE REPORTER FOUND THE PATIENT IN THE HOUSE WHEN THE NO PRIME ALARM WENT OFF AND PROMPTLY TREATED HER WITH SUGAR WATER. THE PATIENT WAS GIVEN 15 GRAM OF CARBOHYDRATE AT 9:50 AM WHILE HER BLOOD GLUCOSE TESTED AT 80 MG/DL. IT WAS NOTED THAT THE PATIENT¿S BASAL INSULIN REGIMEN WAS HIGHEST FROM 4 AM TO 10 AM. AT THE TIME OF THE CALL, THE PATIENT WAS OFF OF INSULIN PUMP THERAPY UNTIL HER BLOOD GLUCOSE WAS WITHIN TARGET. THERE WAS NO MALFUNCTION ASSOCIATED WITH THE REPORTED EVENT. THE ADVANCE FEATURES AND THE BASAL SEGMENT ARE CORRECTLY PROGRAMMED ACCORDING TO THE PATIENT¿S USAGE. THE DATE AND TIME WAS CONFIRMED TO BE ACCURATE. THE REPORTER WAS ADVISED TO CONTACT THE PATIENT¿S DOCTOR TO DISCUSS POSSIBLE CHANGES TO HER INSULIN REGIMEN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD A HYPOGLYCEMIC READING OF 40 MG/DL AND REQUIRED ASSISTANCE FROM THE REPORTER WHILE ON THE INSULIN PUMP THERAPY. ALTHOUGH THERE WAS NO MALFUNCTION ASSOCIATED WITH THE REPORTED INCIDENT, THE SUBJECT PUMP COULD NOT BE RULE OUT AS A CONTRIBUTOR THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313481 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| R