BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2193550 · Received August 5, 2011

    Report

    Report Number
    2531779-2011-05647
    Event Type
    Injury
    Date Received
    August 5, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: PUMP HISTORY WAS REVIEWED AND THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE 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. UNRELATED TO THE COMPLAINT, THE PUMP WAS FOUND TO HAVE A MINOR SCUFF ON THE DISPLAY LENS AND THE BATTERY CAP WAS FOUND TO BE STRIPPED BUT WAS ABLE TO MAINTAIN POWER.

    Additional Manufacturer Narrative · 1

    CUSTOMER SUPPORT OBTAINED THE FOLLOWING FOLLOW-UP INFORMATION FROM A FAMILY MEMBER ON (B)(6) 2011: THE FAMILY MEMBER REPORTED THAT THE PATIENT'S REPORTED BG EXCURSION RESOLVED WITH A SUPPLY CHANGE. SHE STATED THAT THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION, AND DENIED SIGNS AND SYMPTOMS OF HYPERGLYCEMIA. THE FAMILY MEMBER DECLINED TROUBLE SHOOTING OF THE PUMP, AS THE PATIENT'S BG RETURNED TO NORMAL RANGE AFTER CHANGING SUPPLIES.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING BLOOD GLUCOSE (BG) READINGS OF HIGH (GREATER THAN 600 MG/DL) ON THE METER, AND HAS BEEN UNABLE TO CONTROL HER BGS. SHE STATED THAT THE HEALTH CARE PROVIDER ALLOWS THEM TO MAKE ADJUSTMENTS ON THE PUMP SETTINGS AS NEEDED, AND ADJUSTMENTS HAVE BEEN UNSUCCESSFUL IN CONTROLLING THE PATIENT'S ERRATIC BGS. THERE WAS NO SPECIFIC DATE GIVEN FOR THE REPORTED BG EXCURSIONS. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    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 11 YR Other