BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3053415 · Received April 11, 2013

    Report

    Report Number
    2531779-2013-04077
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 06/28/2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THE LAST BOLUS AND BASAL DELIVERY WAS ON (B)(6) 2013. IT WAS OBSERVED WHEN REVIEWING THE TDD, THE TIME AND DATE WAS FOUND TO BE MANUALLY SET. THE TDD HISTORY WAS FOUND TO GO FROM (B)(4) 2013 TO (B)(4) 2013. THE BLACK BOX HISTORY INDICATED NO DATE FOR THE DATES NOTED ABOVE. NO PRIME WAS RECORDED ON (B)(6) 2013. ONLY TYPICAL USAGE ALARMS AND WARNING WERE RECORDED IN THE PUMP ALARM HISTORY. THE TDD WAS FOUND TO ADD UP CORRECTLY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. THE REPORTED COMPLAINT COULD NOT BE DUPLICATED DURING THE INVESTIGATION. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE DISCOLORED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT AND HIS MOTHER REPORT THE PATIENT HAS BEEN HAVING ELEVATED BLOOD GLUCOSES (BG), 200 MG/DL DESPITE BOLUSING, SINCE THE BEGINNING OF MARCH. 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 TECHNICAL SUPPORT (CTS) WALKED PATIENT THROUGH CHECKING HIS PUMP SETTINGS, I:C RATIO, BASAL RATES, BG TARGET, ISF, IOB ALL PROGRAMMING WAS DESIRED PER PATIENT. PRIME HISTORY SHOW PATIENT CHANGING SITE EVERY THREE DAYS WITH APPROPRIATE AMOUNT OF INSULIN, PT DOES NOT ALWAYS FILL CANNULA STEP PER PUMP, BUT PATIENT REPORTS THAT HE DOES. TDD IS ADDING UP CORRECTLY. BOLUS HISTORY AMOUNTS ARE ALL GIVEN TO COMPLETION AND AS DESIRED. NO RECENT ALARMS IN PUMP HISTORY. PATIENT'S MOTHER REPORT SITES LOOK GOOD NO BUMPS, NO BRUISING, NO BLEEDING OR LEAKING AT SITE. PATIENT REPORTS HE ROTATES AROUND ABDOMEN, THIGHS AND ARMS. MOTHER REPORTS THEY HAVE SPOKEN WITH THEIR ENDOCRINOLOGIST AND THE PUMP NEEDS TO BE REPLACED. CTS INSTRUCTED MOTHER AND PATIENT THAT NOTHING IS FOUND TO BE WRONG WITH THE PUMP. THE BG EXCURSIONS DO NOT MEET THE CRITERIA FOR AN ADVERSE EVENT. THE COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION OF A NON-SPECIFIC PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156724 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR