BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3021453 · Received March 26, 2013

    Report

    Report Number
    2531779-2013-03070
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. 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 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER, A CERTIFIED DIABETES EDUCATOR (CDE), CONTACTED ANIMAS AND ALLEGED THAT A PATIENT HAD BEEN IN HOSPITAL ON (B)(6) 2013 FOR DIAGNOSIS OF DIABETIC KETOACIDOSIS (DKA) THE CDE HAS BEEN FOLLOWING PATIENT POST HOSPITALIZATION AND HIS BLOOD GLUCOSE (BG) LEVELS HAVE BEEN ELEVATED, RANGING IN 200MG/DL-300MG/DL. WHEN HE GIVES MANUAL INJECTIONS, HIS BG RETURNS TO NORMAL. THIS HAS OCCURRED FOR PAST FEW WEEKS. CDE STATES HE IS ROTATING SITES. CUSTOMER TECHNICAL SUPPORT (CTS) CALLED PATIENT TO GET INFORMATION REGARDING HOSPITALIZATION: HE WAS ADMITTED TO ICU, WITH A DIAGNOSIS OF DKA AND A BG OF 760MG/DL. TRANSFERRED TO REGULAR ROOM ON (B)(6) AND DISCHARGED ON (B)(6) ON PUMP. PATIENT HAS BEEN ON PUMP UNTIL TODAY WHEN HIS HEALTHCARE PROVIDER (HCP) ADVISED TO COME OFF PUMP AND GET A REPLACEMENT PUMP. HE IS CURRENTLY ON A BACKUP PLAN. PATIENT WAS VERY UPSET THAT WHEN HE CALLED IN BEFORE HE WAS ADVISED THAT HE WAS NOT INSERTING INFUSION SETS PROPERLY. HE STATES HE HAS DONE THIS NUMEROUS TIMES AND A1C ARE VERY GOOD, BELOW 7.0. PATIENT DID NOT WANT TO REVIEW, SO CTS CANNOT DETERMINE OTHER FACTORS WITH PUMP. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT A PATIENT ON PUMP THERAPY EXPERIENCED DKA RELATED TO A NONSPECIFIC PUMP ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123099 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization