BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2173016 · Received July 23, 2011

    Report

    Report Number
    2531779-2011-05131
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: NO INSULIN DELIVERY 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. NO POWER ISSUES OCCURRED DURING TESTING. PUMP TIME AND DATE WAS SET; PUMP EXERCISED FOR 24 HOURS. THE BATTERY WAS REMOVED. PUMP LEFT WITHOUT POWER FOR 6 HOURS; WHEN PUMP POWERED ON IT HAD RETURNED TO DEFAULT TIME AND DATE. PUMP OPENED AND THE INTERNAL BATTERY FOUND TO BE LEAKING.

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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

    A FAMILY MEMBER REPORTED THAT ON (B)(6) 2011 THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH BLOOD GLUCOSE (BG) OVER 600 MG/DL, KETONES, AND EMESIS. SHE STATED THAT THE PATIENT RECEIVED A DIAGNOSIS OF DIABETIC KETOACIDOSIS (DKA), WAS REMOVED FROM THE PUMP AND PLACED ON AN INSULIN DRIP. SHE STATED THAT THE PATIENT'S BG DECREASED TO AROUND 200 MG/DL WHILE ON THE INSULIN DRIP, BUT BEGAN TO ELEVATE AGAIN WHEN PLACED BACK ON THE PUMP. THE FAMILY MEMBER REPORTED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011 ON INJECTION THERAPY. SHE STATED THAT THE PATIENT'S BG REMAINED AROUND 200 MG/DL WHILE ON INJECTIONS. CUSTOMER SUPPORT REVIEWED THE PUMP WITH THE FAMILY MEMBER AND THE PATIENT, AND FOUND THAT THERE WERE NO MECHANICAL ISSUES WITH THE PUMP. THE BOLUS HISTORY AND TOTAL DAILY DOSE HISTORY ADDED UP; THERE WERE NO SIGNIFICANT ALARMS FOUND IN THE PUMP HISTORY; THE PATIENT WAS ABLE TO PRIME INTO THE AIR WITHOUT ANY ISSUES. THE PATIENT REPORTED THAT THERE WERE NO AIR BUBBLES IN THE TUBING OR CARTRIDGE, AND THERE WERE NO BENT CANNULAS. HE STATED THAT HE CHANGED INFUSION SETS/SITES (B)(6), AND WAS USING HIS LOWER HIP AREA FOR INFUSION SET INSERTION. THE PATIENT STATED THAT HE WAS USING A DIFFERENT SITE FOR INJECTIONS THAN FOR INSULIN PUMP THERAPY. (B)(4) RECOMMENDED THAT THE PATIENT CONTACT HIS HEALTH CARE PROVIDER TO DISCUSS POSSIBLE SCAR TISSUE AND SITE SELECTION, AS THE PATIENT HAS BEEN USING THE SAME SITE FOR (B)(6). THE PUMP IS NOT BEING RETURNED AT THIS TIME, AND THERE HAS BEEN NO FURTHER REPORTED INCIDENT. THIS COMPLAINT IS BEING REPORTED BASED ON THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY.

    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 14 YR Hospitalization