BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3231603 · Received July 17, 2013

    Report

    Report Number
    2531779-2013-11078
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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 10/03/2013 ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 9/12/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS ALLEGING THAT ON (B)(6) 2013, SHE WAS TAKEN TO THE HOSPITAL FOR DEHYDRATION AND ELEVATED BLOOD GLUCOSE (BG). THE PATIENT WAS REPORTEDLY RELEASED FROM THE HOSPITAL ON (B)(6) 2013. THE PATIENT WAS A POOR HISTORIAN AND COULD NOT PROVIDE DETAILS SUCH AS BG VALUES AND TREATMENT. THE HEALTHCARE PROVIDER (HCP) REPORTEDLY TOLD THE PATIENT THAT THEY FELT THE PUMP WAS MALFUNCTIONING AND ADVISED HER TO COME OFF THE PUMP. THE PATIENT REPORTEDLY CONTINUED ON INSULIN PUMP THERAPY DESPITE HCP RECOMMENDATIONS. CUSTOMER TECHNICAL SUPPORT REVIEWED THE PUMP WITH THE PATIENT AND FOUND THE ALARM HISTORY SHOWED NORMAL USE AND THE TOTAL DAILY DOSE HISTORY SHOWED THE BASAL RATE WAS DELIVERING APPROPRIATELY; HOWEVER, A REVIEW OF THE BOLUS HISTORY DID NOT SHOW ENOUGH BOLUSES. THE BOLUS HISTORY SHOWED ONLY TWO BOLUSES ON (B)(6) 2013, THREE BOLUSES ON (B)(6) 2013, NO BOLUSES ON (B)(6) 2013, ONE BOLUS ON (B)(6) 2013, AND NO BOLUSES ON (B)(6) 2013. THE PATIENT STATED THAT SHE PROGRAMMED MORE BOLUSES THAN WHAT WAS RECORDED IN THE BOLUS HISTORY. THE PATIENT NOTED THAT SHE HAS MULTIPLE SCLEROSIS AND IS TAKING SEVERAL MEDICATIONS: TRAZADONE, VITAMIN D3, BACLOSEN, DIAZEPAM, PROXETINE XL, CARISOPROL, TOSLTERODINE, SIMVASTATIN, AND ASA COPAXONE. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PUMP WAS MALFUNCTIONING AND THE PATIENT EXPERIENCED HYPERGLYCEMIA REQUIRING MEDICAL INTERVENTION, AND DUE TO THE ALLEGED BOLUS HISTORY DISCREPANCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331634 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L| R