BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2873002 · Received December 13, 2012

    Report

    Report Number
    2531779-2012-14547
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    December 6, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THERE WAS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX AND DOWNLOAD HISTORY. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THERE WAS NO DEFECT FOUND ON INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 PATIENT CONTACTED ANIMAS ON (B)(6) 2012 REPORTING BLOOD GLUCOSE LEVELS AS HIGH AS 25 MMOL/L WITH SYMPTOMS OF FATIGUE, NAUSEA, VOMITING, ABDOMINAL CRAMPS, SEVERE THIRST, AND FREQ URINATIONS. THE PATIENT CONFIRMED THAT THERE WERE NO ABNORMALITIES NOTED AT THE SITE. THE PATIENT REPORTED THAT A HEALTH CARE PROFESSIONAL PROVIDED A DEMO PUMP AND MADE ADJUSTMENTS TO THE INSULIN REGIMEN AND BLOOD GLUCOSE LEVELS RESOLVED TO NORMAL. THE HEALTH CARE PROFESSIONAL REPORTEDLY FELT THAT THE EVENT WAS RELATED TO AN ISSUE WITH THE PUMP. THE PATIENT CONFIRMED THAT ALL OF THE PUMP SETTINGS WERE CORRECT. THE REVIEW OF THE PUMP TOTAL DAILY DOSE HISTORY INDICATED NO DELIVERY FROM 12AM TO 4AM BUT THE PATIENT STATED THAT THE PUMP WAS NOT IN SUSPEND OR TURNED OFF AT THAT TIME. ALL OTHER PUMP ENTRIES WERE CONSISTENT WITH THE BASAL PROGRAM. THERE WERE NO RELEVANT ALARMS IN THE PUMP HISTORY. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WITH AN ALLEGATION THAT THE PUMP MAY NOT HAVE BEEN DELIVERING CORRECTLY.

    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 48 YR Life Threatening| R