BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2091549 · Received May 17, 2011

    Report

    Report Number
    2531779-2011-03459
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/07/2014 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA FOUND THE CURRENT DATE RANGE DID NOT COVER THE COMPLAINT DATE DUE TO CUSTOMER CONTINUED USE. REVIEW OF THE CURRENT DATE RANGE DID NOT FIND ANY WARNINGS OR ALERTS RELATED TO THE COMPLAINT AND THE TOTAL DAILY DELIVERIES ADDED UP CORRECTLY AND REFLECTED THE USER¿S PROGRAMMED BASAL SETTINGS. THE CAPS WERE NOT RETURNED AND TEST CAPS WERE USED IN THE INVESTIGATION. THE PUMP POWERED UP WITH AUDITORY AND VIBRATORY FEATURES. NO TACTILE ISSUE WAS OBSERVED WITH THE BUTTONS. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR PUMP EXERCISE WERE EXECUTED WITHOUT INCIDENCES. THE PUMP DELIVERY ACCURACY WAS WITHIN SPECIFICATIONS. BOLUS EXERCISES WERE COMPLETED AND RECORDED CORRECTLY. THE INVESTIGATION WAS UNABLE TO VERIFY THE REPORTED ISSUE IN THE BLACK BOX OR DUPLICATE THE COMPLAINT. UNRELATED TO THE REPORTED ISSUE, THE FORCE SENSOR CALIBRATION WAS FOUND LOW OUT OF SPECIFICATIONS WHILE THE FORCE SENSOR RESISTANCE READING WAS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THE PATIENT HAD A LOW BLOOD GLUCOSE READING OF 45 MG/DL DUE TO A USER ERROR. THE REPORTER INADVERTENTLY CLEARED THE INSULIN ON BOARD AND TOOK TOO MUCH INSULIN. THE REPORT INDICATED THAT SHE DID NOT TAKE INTO ACCOUNT THE INSULIN ON BOARD AND BOLUSED FOR A BLOOD GLUCOSE READING OF 290 MG/DL. ONE HOUR LATER, THE PATIENT TESTED AT 45 MG/DL WITH SYMPTOMS DESCRIBED AS ACTIVE, ALERT, BUT MORE EMOTIONAL THAN USUAL. THE PATIENT'S MOTHER TREATED HIM FOR THE LOW BLOOD GLUCOSE. AT THE TIME OF THE CALL TO ANIMAS, THE PATIENT'S BLOOD GLUCOSE WAS 93 MG/DL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY SUFFERED A HYPOGLYCEMIC EPISODE AFTER THE REPORTER INADVERTENTLY GAVE TOO MUCH INSULIN VIA THE ANIMAS PUMP.

    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 3 YR Life Threatening| R