BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3070936 · Received April 22, 2013

    Report

    Report Number
    2531779-2013-04745
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. 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. THE PUMP HAS BEEN RETURNED TO ANIMAS BUT 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 (B)(4) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP¿S HISTORY CONFIRMED A 2.5 UNIT EZCARB BOLUS AT 04:29 (B)(6) 2013. THE CURRENT TOTAL DAILY BASAL DELIVERIES WERE CORRECT AND BOLUS DELIVERIES WERE CORRECTLY REFLECTED IN THE DAILY INSULIN DELIVERY TOTALS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO UNPROGRAMMED BOLUSES. A NORMAL 10 UNIT BOLUS AND 10 UNIT AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND RECORDED ACCURATELY IN THE PUMP¿S HISTORY. NO DAMAGE WAS FOUND THE KEYPAD AND ALL THE BUTTONS WERE FOUND TO BE RESPONSIVE WITH NO HYPERSENSITIVITY. THE KEYPAD COVER WAS REMOVED AND NO CONTAMINATION OR INVERTED KEY CONTACTS WERE FOUND.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING THAT SHE EXPERIENCED LOW BLOOD GLUCOSE (BG) OF 89 MG/DL THAT MORNING WITH MILD SHAKINESS AS A RESULT OF THE PUMP DELIVERING AN UNPROGRAMMED BOLUS OF 2.5 UNITS OF INSULIN AT 4:29 AM WHILE THE PATIENT WAS ASLEEP. THE PATIENT REPORTED THAT SHE TREATED THE LOW BG BY CONSUMING FOOD AND THE BG BECAME ELEVATED TO 114 MG/DL. THE REPORTED LOW BG DOES NOT MEET ANIMAS' CRITERIA FOR A REPORTABLE ADVERSE EVENT; THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PATIENT DENIED ANY USER INTERVENTION THAT WOULD HAVE RESULTED IN THE ADMINISTRATION OF THE 2.4 UNIT INSULIN BOLUS THAT WAS VERIFIED AS BEING RECORDED IN THE PUMP'S BOLUS HISTORY AT 4:29 AM THAT MORNING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION REMAINED RESOLVED WITH TROUBLESHOOTING BY ANIMAS CUSTOMER TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171985 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR