BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2870769 · Received December 12, 2012

    Report

    Report Number
    2531779-2012-14486
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 16, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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

    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. A REVIEW OF THE BLACK BOX AND PRIME HISTORY SHOWS LOW PRIME VOLUMES DURING CARTRIDGE CHANGES ON (B)(6) 2012. ONE "LOSS OF PRIME" WARNING WAS OBSERVED ON (B)(6) 2012. A REWIND, LOAD, AND PRIME SEQUENCE WAS SUCCESSFULLY PERFORMED WITH NO ALARMS OCCURRING. 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. A "LOSS OF PRIME" WARNING WAS INDUCED DURING TESTING AND THE PUMP EMITTED THE APPROPRIATE AUDIO-VISUAL ALERT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: SHE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2012 WITH A DIAGNOSIS OF DIABETIC KETOACIDOSIS (DKA). HER PUMP WAS REMOVED AND INTRAVENOUS THERAPY WAS STARTED IN THE INTENSIVE CARE UNIT (ICU). ON (B)(6) 2012 PUMP THERAPY WAS RESTARTED, WITH NEW SET/SITE AND INSULIN AND HER BLOOD GLUCOSE (BG) ROSE AGAIN. SHE REPORTED IT WAS NOT THE SET, SITE OR INSULIN, HAD TO BE THE PUMP, AND HER HEALTH CARE PROVIDERS ARE INSISTING ON REPLACING THE PUMP. THE PATIENT IS CURRENTLY IN HOSPITAL, NOT ON PUMP, BUT WAITING TO GO BACK ON PUMP THERAPY. THE PATIENT REPORTS THERE HAVE BEEN NO ALARMS OR SUSPENSION, AND ALL SETTINGS ARE AS DESIRED. TROUBLESHOOTING FOUND NO PUMP MALFUNCTION. THIS COMPLAINT IS BEING REPORTED TO DUE THE ALLEGATION THAT A PATIENT ON PUMP THERAPY DEVELOPED DKA.

    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 55 YR Hospitalization