BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2761120 · Received September 26, 2012

    Report

    Report Number
    2531779-2012-11312
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    August 28, 2012
    Report Date
    August 28, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/10/2015 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY (B)(6) BATTERY. WHEN A NEW (B)(6) BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED. UNABLE TO REVIEW ALARM/BB HISTORY FOR EAW RELATED TO THE COMPLAINT; DATA HAS BEEN OVERWRITTEN. ACCURACY FLOW TEST WAS COMPLETED WITH NO DELIVERY DEFECTS FOUND. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS TO REPORT THAT SHE HAD BEEN OBTAINING ELEVATED BLOOD GLUCOSE (BG) READINGS SINCE CONNECTING TO THE SUBJECT PUMP. AT THE TIME OF THE CALL THE PATIENT REPORTED OBTAINING A BG OF 537 MG/DL AT 5:30PM THAT EVENING. THE PATIENT INFORMED CUSTOMER SUPPORT THAT SHE TESTED NEGATIVE FOR KETONES AND DID NOT HAVE ANY SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA. THE PATIENT REPORTED BOLUSING FOR THE HIGH BG AND HER BG RESPONDED QUICKLY. AT THE TIME OF THE CALL, THE PATIENT REPORTED THAT SHE REALIZED THE TIME ON THE SUBJECT PUMP WAS INCORRECT. THE PATIENT CLAIMED WHEN SHE RECEIVED NEW PUMP SHE ACCIDENTALLY MIXED UP THE AM/PM SETTING WHEN PROGRAMMING THE NEW PUMP. IT WAS NOTED THAT THE PATIENT WAS RECEIVING THE WRONG BASAL AND CALCULATING THE WRONG BOLUSES DUE TO THE INCORRECT TIME. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT OBTAINED A BG READING GREATER THAN 500 MG/DL WHILE ON INSULIN PUMP THERAPY. THE PATIENT'S ALLEGED HYPERGLYCEMIA CAN BE ATTRIBUTED TO USE ERROR SINCE THE PATIENT ACKNOWLEDGED ACCIDENTALLY SETTING THE PUMP TO THE INCORRECT TIME WHEN SHE RECEIVED IT.

    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 18 YR Life Threatening| R