BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3203704 · Received July 3, 2013

    Report

    Report Number
    2531779-2013-09563
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    June 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/22/2013 WITH THE FOLLOWING FINDINGS: THE TOTAL DAILY DOSE ADDS UP CORRECTLY. THE PUMP POWERS ON AND DISPLAYS VERIFY SCREEN. THE PUMP WAS PRIMED AND IT WAS EXERCISED FOR 24 HOURS, NO ALARMS OCCURRED DURING THE COURSE OF THE DURATION TEST. THE FORCE SENSOR CALIBRATION READING IS WITHIN THE REQUIREMENT. THE PUMP PASSED 29 HOUR FLOW ACCURACY AND IT WAS FOUND ABLE TO DELIVER WITHIN THE REQUIRED SPECIFICATIONS. THERE WAS NO DEFECT FOUND.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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, IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013 WITH A DIAGNOSIS OF DKA. IT WAS STATED THAT THE PATIENT WAS SICK (UNSPECIFIED SYMPTOMS) AND THEN ON (B)(6) 2013 THERE WERE COMPLAINTS OF NAUSEA, SEVERE VOMITING, AND DIZZINESS; BLOOD GLUCOSE (BG) READINGS WERE ABOVE 300MG/DL. THE REPORTER SAID THAT THE PATIENT REMAINED ON AN ALTERNATE FORM OF INSULIN DELIVERY IN THE HOSPITAL UNTIL (B)(6) 2013 WHEN THE PATIENT RESUMED PUMP THERAPY; BG ROSE TO 257MG/DL AND PUMP THERAPY WAS DISCONTINUED. PER THE REPORTER, THE PATIENT¿S DOCTOR CLAIMED THAT THE PUMP WAS NOT DELIVERING INSULIN AND THE PUMP WAS REPLACED CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED THE PUMP WITH THE REPORTER: NO ISSUES WITH INFUSION SETS (IFS) OR SITES WERE REPORTED. HOWEVER, ACCORDING TO THE PRIME HISTORY THE MOST RECENT RECORD OF IFS REPLACEMENT WAS ON (B)(6) 2013. THERE WAS NO INDICATION THAT THE IFS WAS CHANGED IN THE HOSPITAL. USUAL PRACTICE IS TO CHANGE THE IIFS EVERY 3 DAYS AND THE CARTRIDGE IS REPLACED WITH EVERY 3RD OR 4TH IFS CHANGE. THE PRIME HISTORY INDICATED THAT THE IFS WERE CHANGED AT BEDTIME, THE PRIME AMOUNTS WERE SOMETIMES INADEQUATE, AND THE CANNULAS WERE NOT ALWAYS BEING FILLED. THERE WERE NO RELEVANT ALARMS IN THE HISTORY. ALL SETTINGS WERE CONFIRMED TO BE CORRECT; ALL BOLUS AND BASAL DELIVERIES WERE ACCURATE. ON (B)(6) 2013, THE BOLUS HISTORY SHOWED ONLY 4 BOLUSES AND THERE WAS NO INDICATION THAT CORRECTION INSULIN WAS DELIVERED VIA SYRINGE OR PEN. ON (B)(6) 2013, THERE WAS ONLY ONE BOLUS IN THE HISTORY AT 3:24PM. CTS CONCLUDED THAT THERE WERE NO APPARENT DELIVERY ISSUES BUT THAT SEVERAL USE ERRORS HAD OCCURRED. THE REPORTER WAS INSTRUCTED HOW TO CORRECT THESE ERRORS IN ORDER TO PREVENT FURTHER EPISODES OF HYPERGLYCEMIA. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSIONS: SEVERAL INSTANCES OF INCORRECT TECHNIQUES WERE DISCOVERED BUT THE PATIENT'S PHYSICIAN CLAIMED THAT THE PUMP DID NOT DELIVER ADEQUATE INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305469 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization