BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3231754 · Received July 17, 2013

    Report

    Report Number
    2531779-2013-11083
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 18, 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

    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. THE PUMP HISTORY SHOWED THAT AN AUTO OFF ALARM OCCURRED ON (B)(6) 2013 AT 5:08 AM; INSULIN DELIVERY WAS NOT RESUMED AFTER THE ALARM. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. AN AUTO OFF ALARM WAS DUPLICATED DURING TESTING AND THE PUMP EMITTED THE APPROPRIATE AUDIBLE ALERT AND DISPLAYED THE APPROPRIATELY WARNING MESSAGE. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    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.

    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 DIABETIC KETOACIDOSIS. THE PATIENT WAS REPORTEDLY NOT THINKING CLEARLY. THE PATIENT DENIED NAUSEA OR VOMITING AND CONFIRMED SHE WAS DRINKING AND URINATING NORMALLY. BLOOD GLUCOSE (BG) VALUES RELATED TO THE REPORTED INCIDENT WERE NOT PROVIDED. THERE WERE NO REPORTED SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE PATIENT WAS A POOR HISTORIAN AND COULD NOT PROVIDE DETAILS OF 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 HAD REPORTEDLY BEEN ADVISED BY AN HCP TWICE PREVIOUSLY TO COME OFF THE PUMP, BUT CONTINUED ON INSULIN PUMP THERAPY AGAINST HCP ADVICE. 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. THERE WAS NO BOLUS HISTORY PROVIDED FOR (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. USE ERROR WAS DETERMINED TO BE A CONTRIBUTOR IN THE ALLEGED INCIDENT, AS THE PATIENT CONTINUED TO USE A PUMP THAT WAS BELIEVED TO BE MALFUNCTIONING. THE PATIENT¿S HCP REQUESTED THE PUMP BE REPLACED, AND THE PATIENT WAS ON INSULIN INJECTIONS AT THE TIME OF THE CALL TO ANIMAS, AWAITING A PUMP REPLACEMENT. 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
    332584 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| R