BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3181823 · Received June 21, 2013

    Report

    Report Number
    2531779-2013-08727
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/28/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY SHOWED THAT THE LAST BOLUS AND LAST BASAL DELIVERIES OCCURRED ON (B)(6) 2013. THE PUMP WAS NOT IN USE FROM (B)(6) 2013 TO (B)(6) 2013. THERE WERE NO ALARMS OUTSIDE NORMAL USE OBSERVED ON THE PUMP HISTORIES. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. NO ALARMS OCCURRED DURING TESTING. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THE COMPLAINT OF INACCURATE DELIVERY COULD NOT BE CONFIRMED OR DUPLICATED ON INVESTIGATION. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED.

    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. 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) 2013, THE PATIENT CONTACTED ANIMAS ALLEGING THAT SHE HAD BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE (BG) UP TO 600MG/DL FOR THE PAST TWO TO THREE WEEKS AND CANNOT FIND AN EXPLANATION FOR THE HIGH BGS. THE PATIENT REPORTED SYMPTOMS OF THIRST AND EXTREME LETHARGY WITH ELEVATED BGS. THE PATIENT STATED THAT SHE BOLUSES TO CORRECT HIGH BGS AND GIVES CORRECTION INJECTIONS WHEN BGS DON¿T RESPOND TO BOLUSES. THE PATIENT ALSO MENTIONED OCCASIONAL LOW BGS BUT DID NOT PROVIDE ANY BG VALUES OR SIGNS/SYMPTOMS FOR THE LOWS. THE PATIENT STATED THAT WITH ONE LOW BG THE PRIOR WEEK SHE FELT ILL AND ¿HAD TO EAT BROWN SUGAR¿. THE PATIENT WAS ANXIOUS ABOUT THE HIGH BGS AND BELIEVED THE PUMP WAS NOT DELIVERING APPROPRIATELY. CUSTOMER TECHNICAL SUPPORT REVIEWED THE PUMP AND FOUND ALL SETTINGS AND HISTORIES WERE CORRECT. TROUBLESHOOTING INDICATED THE PUMP WAS DELIVERING AS PROGRAMMED, HOWEVER, THE PUMP WAS REPLACED AT THE REQUEST OF THE PATIENT. THE PATIENT WAS INSTRUCTED TO CONTACT HER HEALTHCARE PROVIDER FOR A BACK-UP PLAN UNTIL A REPLACEMENT PUMP ARRIVES. THE REPORTED LOW BGS DO NOT MEET CRITERIA FOR A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA OF UNKNOWN CAUSE AND THE ALLEGATION THAT THE PUMP WAS NOT DELIVERING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281894 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening