BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3210961 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09783
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    June 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/20/2013 WITH THE FOLLOWING FINDINGS: THE PUMP WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATION AT THE CONCLUSION OF THE 29 HOUR FLOW ACCURACY TEST. THE COMPLAINT COULD NOT BE DUPLICATED DURING THE INVESTIGATION.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: HE HAS HAD A ¿HI¿ READING AT LEAST ONCE A DAY ON HIS PUMP SINCE (B)(6) 2013. HE WAS IN THE 400MG/DL ALL YESTERDAY AND 505MG/DL BEFORE BED LAST NIGHT. HE WAS 234MG/DL AT 2AM THIS MORNING AND AT BREAKFAST WAS ELEVATED AGAIN TO ¿HI.¿ HE DOES NOT FEEL ANY SYMPTOMS WITH HIS HIGH BG¿S AND ONLY KNOWS HE¿S HIGH WHEN THE BG MONITOR TELLS HIM SO. THE PATIENT AND HIS DAUGHTER SPOKE WITH HIS ENDOCRINOLOGIST THIS MORNING , WHO RECOMMENDED HE GOES OFF OF THE PUMP AND INJECTS WITH HUMALOG AND DAILY LANTUS, BECAUSE THE ENDOCRINOLOGIST DOES NOT THINK THE PUMP IS WORKING CORRECTLY. THE PATIENT STARTING USING AN ALTERNATIVE INSULIN DELIVERY REGIMEN AT LUNCH TIME TODAY. PATIENT DOES NOT TEST FOR KETONES, AND HAS NOT REQUIRED HOSPITALIZATION FOR THESE BLOOD GLUCOSE (BG) EXCURSIONS. PATIENT REPORTS NO NEW MEDICATIONS, NO NEW ACTIVITIES/STRESSORS, NO NEW DIET CHANGES REPORTED. TIME AND DATE ARE CORRECT IN PUMP. INSULIN IS STORED APPROPRIATELY AND IS NOT EXPIRED. CUSTOMER SUPPORT (CS) WALKED HIM THROUGH CHECKING HIS PUMP SETTINGS: I:C RATIO, BASAL RATES, BG TARGET, ISF, IOB ALL PROGRAMMED AS DESIRED PER PATIENT. PRIME HISTORY SHOW PATIENT CHANGING SITE EVERY THREE DAYS WITH APPROPRIATE AMOUNT OF INSULIN. TDD IS ADDING UP CORRECTLY. BOLUS HISTORY AMOUNTS ARE ALL GIVEN TO COMPLETION AND AS DESIRED PER PATIENT. ONE OCCLUSION ALARM IN ALARM HISTORY FROM JUNE 5TH, PATIENT REPORTS TUBING WAS KINKED AND HE REDELIVERED THAT BOLUS SOON AFTER. NO OTHER RECENT ALARMS IN PUMP HISTORY, PATIENT REPORT SITES LOOK GOOD NO BUMPS, NO BRUISING, NO BLEEDING OR LEAKING AT SITE. PATIENT DOES NOT ROTATE SITES, HAS ALWAYS USED ABDOMEN SINCE STARTING ON THE PUMP IN 2002. CUSTOMER SUPPORT (CS) ADVISED PATIENT THAT PUMP WILL BE REPLACED UNDER WARRANTY BECAUSE OF THE PHYSICIANS¿ ORDER, BUT THAT HE SHOULD DISCUSS POSSIBLE SETTING ADJUSTMENTS AND ROTATING INFUSION SITES TO BETTER USE THE PUMP. THIS ISSUE IS BEING REPORTED BECAUSE A PATIENT ON PUMP THERAPY EXPERIENCED HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310510 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Life Threatening