BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2870994 · Received December 12, 2012

    Report

    Report Number
    2531779-2012-14510
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    November 21, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/11/2014 WITH THE FOLLOWING RESULTS: A REVIEW OF THE PUMP¿S HISTORY SHOWED THAT INFORMATION FROM THE EVENT DATE WAS OVERWRITTEN IN THE PUMP¿S HISTORY DUE TO CONTINUED USE OF THE PUMP. THE LAST BASAL DELIVERY WAS ON (B)(6) 2014 AT 05:00. THE PUMP WAS PRIMED AND EXERCISED FOR 24 HOURS WITH NO DELIVERY INTERRUPTION. THE UNIT PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE HCP/REPORTER CONTACTED ANIMAS TO REPORT THE PATIENT WAS HOSPITALIZED FOR DKA WHEN HER BLOOD GLUCOSE READING WAS AT 700 MG/DL. THE EVENT OCCURRED ON (B)(6) 2012 AT 2 AM. THE PATIENT WAS TREATED WITH IV INSULIN IN THE ICU. AFTER REVIEW OF THE INSULIN PUMP HISTORY WITH THE PATIENT'S HCP, IT WAS DISCOVERED THAT THE PATIENT WAS SKIPPING BOLUS INSULIN DOSES. ACCORDING TO THE PATIENT, SHE MAY HAVE CANCELED HER BOLUS INSULIN DOSES BY MISTAKE AS HER BOLUS HISTORY REVEALED ON (B)(6) 2012, SHE RECEIVED 0.0 OF 5.7 UNITS AND ON (B)(6) 2012, SHE RECEIVED 8.2 OF 19.2 UNITS. THE PATIENT'S MOM INDICATED THAT THE PATIENT'S HOSPITALIZATION WAS DUE TO USE ERROR. THE PATIENT'S BLOOD GLUCOSE READINGS ARE BACK TO NORMAL WHILE SHE IS CURRENTLY ON INSULIN PUMP THERAPY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REQUIRED MEDICAL INTERVENTION FOR ACUTE COMPLICATION OF DIABETES WHILE ON INSULIN PUMP THERAPY. USE ERROR (INADVERTENTLY CANCELING HIS BOLUS INSULIN) INVOLVING THE SUBJECT PUMP COULD NOT BE RULED OUT AS A CONTRIBUTOR OF THE HYPERGLYCEMIC EVENT. HENCE, THIS COMPLAINT IS BEING REPORTED.

    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 11 YR Hospitalization| L| R