BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3073033 · Received April 23, 2013

    Report

    Report Number
    2531779-2013-04915
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    March 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP HISTORY WAS REVIEWED AND SHOWED THE LAST BOLUS AND BASAL DELIVERIES WERE ON (B)(6) 2013. THERE WERE NO BASAL INTERRUPTIONS PRIOR TO THE EVENT ON (B)(6) 2013. THE TOTAL DAILY DOSES ADDED UP CORRECTLY TO REFLECT THE USERS PROGRAMMED BASAL RATES SHOWING THE PUMP WAS DELIVERING ACCURATELY UP UNTIL THE LAST DATE USED BY THE PATIENT. THERE WERE NO ALARMS RELATED TO THE COMPLAINT IN THE BLACK BOX OR ALARM HISTORY, ONLY TYPICAL USAGE WAS OBSERVED. THE PUMP WAS TESTED ON A (B)(4) FLOW TEST; THE PUMP WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. THE COMPLAINT OF INACCURATE INSULIN DELIVERY WAS NOT DUPLICATED DURING THE INVESTIGATION.

    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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) /2013, REPORTING THAT THE PATIENT IS IN THE INTENSIVE CARE UNIT ON AN INSULIN DRIP AND THE PATIENT'S DOCTOR WOULD LIKE THE PUMP REPLACED BEFORE THEY WILL DISCHARGE HIM. THE REPORTER STATED THAT THE DOCTOR'S STATE THE INFUSION SET WAS GOOD AND THERE WERE NO BENT CANNULAS. THE PATIENT ROTATES ALL AROUND HIS SIDES AND ABDOMEN. THE REPORTER STATED THAT THE DOCTORS CONFIRMED SETTINGS ARE APPROPRIATE FOR THE PATIENT AND CORRECT ON THE PUMP. THE SITE WAS GOOD, NO BUMPS, BRUISING, BLEEDING OR LEAKING AT THE SITE. THE PATIENT WAS REPORTEDLY VOMITING ON (B)(6) 2013, BUT UNSURE IF VOMITING BEGAN AFTER OR BEFORE HIGH BLOOD GLUCOSE (BG). THE PATIENT WAS TAKEN TO THE HOSPITAL ON (B)(6) /2013. THE REPORTER STATED THAT THE BG UPON ADMISSION WAS 1200MG/DL. THE PHYSICIAN IS INSISTING THAT THE PUMP BE REPLACED. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT DUE TO AN ALLEGED HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173835 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L