BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3760106 · Received April 18, 2014

    Report

    Report Number
    2531779-2014-10567
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 26, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING RESULTS: THE COMPLAINT WAS NOT DUPLICATED DURING TESTING. THE PUMP HISTORY SHOWS MANUAL SUSPENDS AND MANUAL RESUMES ON THE DATE OF THE EVENT (B)(6) 2014. THE KEYPAD IS FULLY INTACT AND FULLY RESPONSIVE TO USER PRESSES. NO HYPERTENSIVE KEYS WERE OBSERVED. NO SUSPENDS OCCURRED DURING 24HR DURATION TESTING. PUMP WAS ABLE TO BE MANUALLY SUSPENDED AND MANUALLY RESUMED FOR THE INVESTIGATION. LOSS OF PRIME WARNING OBSERVED IN THE BLACK BOX AFTER RESUMING SUSPEND; THIS WARNING DOES NOT RECORD IN THE ALARM HISTORY. NO LOSS OR PRIMES DUPLICATED DURING THE INVESTIGATION. THE PUMP CLEARLY DISPLAYS MESSAGE ¿DISCONNECT INFUSION SET FROM YOUR BODY!" ON THE REWIND SCREEN AND ¿BE SURE SET IS DISCONNECTED FROM YOUR BODY. THEN SELECT CONTINUE" ON THE PRIME SCREEN. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT IS CRACKED AT THE THREADS. BATTERY CAP WAS NOT RETURNED. A NEW TEST CAP WAS ABLE TO TIGHTEN TO THE PUMP AND WAS USED TO COMPLETE ALL TESTING. 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 REQUESTED FOR RETURN TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. THE PUMP OWNER'S BOOKLET INSTRUCTS THE USER TO NEVER PRIME THE TUBING WHILE THE INFUSION SET IS CONNECTED TO THE BODY TO PREVENT UNINTENDED DELIVERY OF INSULIN.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2014 REPORTING A BLOOD GLUCOSE DOWN TO 43 MG/DL REQUIRING HOSPITALIZATION FOR HYPOGLYCEMIA. THE PATIENT INDICATED THE PUMP HAD ALARMED FOR SOMETHING BUT THERE WAS NO INDICATION IN THE HISTORY OF THE ALARM. THE REPORTER INDICATED THAT THE PHARMACIST PRIMED THE PUMP ATTEMPTING TO CLEAR A SUSPEND ON THE PUMP AND PRIMED 205.3 UNITS WHILE THE PUMP WAS STILL CONNECTED AT THE INFUSION SITE. THE REPORTER INDICATED THAT THE CARTRIDGE WAS NOT FULL AT THE TIME OF THE EVENT AND THAT 50-80 UNITS WERE ALREADY USED AT THAT TIME. THE PATIENT INDICATED THAT WHILE IN THE HOSPITAL FOR THE HYPOGLYCEMIC EVENT, BLOOD GLUCOSE LEVELS REBOUNDED AND ELEVATED UP TO 400 MG/DL. THIS REPORT IS MADE BASED ON THE INDICATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA RELATED TO THE PUMP BEING PRIMED WHILE ATTACHED TO THE PATIENT¿S INFUSION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237524 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L