BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5157003 · Received October 16, 2015

    Report

    Report Number
    2531779-2015-37586
    Event Type
    Injury
    Date Received
    October 16, 2015
    Report Date
    September 27, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    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 (B)(6) 2015 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED A MANUAL DATE/TIME CHANGE FROM (B)(6) 2015 22:46 TO (B)(6) 2015 22:45. THE PUMP POWERED ON TO THE VERIFY SCREEN WITH NO ISSUES. THERE WAS NO DEBRIS OBSERVED IN THE CARTRIDGE COMPARTMENT. A REWIND AND LOAD CARTRIDGE WAS SUCCESSFULLY PERFORMED THEN PRIMED THE CARTRIDGE TO 185U. THE CARTRIDGE WAS REMOVED AND CONFIRMED IT WAS AT 185 UNITS AND THEN REINSTALLED. A REWIND AND LOAD WAS COMPLETED AND THE PISTON CORRECTLY STOPPED AT 185 UNITS AND THE DISPLAY CORRECTLY READ 185U. THE UNITS REMAINING WERE CORRECTLY CALCULATED. THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. 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) 2015, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT ON (B)(6) 2015, THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 37 MG/DL WITH COGNITIVE IMPAIRMENT ASSOCIATED WITH A REMAINING INSULIN READING ISSUE. THIS MALFUNCTION IS BEING RULED OUT BASED ON THE FOLLOWING: THE REPORTER STATED THAT THE PUMP WAS READING GREATER THAN 20 UNITS LESS THAN WHAT WAS ACTUALLY IN THE CARTRIDGE. THE PUMP WILL ALARM PRIOR TO A LOW CARTRIDGE AND THE ALLEGED ISSUE SAID TO BE AN ANNOYANCE OR INCONVENIENCE; THERE WAS NO ALLEGATION THAT THE ALARM COULD NOT BE DETECTED BY THE USER. REPORTEDLY, THE PATIENT REMAINED ON THE INSULIN PUMP AND WAS TREATED WITH ORAL CARBOHYDRATES AS NEEDED. THIS REPORT IS BEING MADE DUE TO THE BG EXCURSION THE PATIENT EXPERIENCED WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688661 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR