BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2250896 · Received September 16, 2011

    Report

    Report Number
    2531779-2011-06851
    Event Type
    Injury
    Date Received
    September 16, 2011
    Report Date
    August 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. (B)(6).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: 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 OCCURRING. AN EZPRIME OPERATION WAS PERFORMED WITH NO DIFFICULTIES NOTED. DURING TESTING THE UNITS REMAINING WERE CORRECTLY CALCULATED. THERE WERE NO PRIME ISSUES NOTED DURING INVESTIGATION. THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) WAS SPORADICALLY GOING AS HIGH AS 500 MG/DL WITH NAUSEA AND VOMITING. THE FAMILY MEMBER REPORTED THAT THE PATIENT WAS TREATED WITH A SHOT OF INSULIN AND THE BG WOULD RESOLVE. THE FAMILY MEMBER STATED THAT SHE FELT THE PUMP WAS NOT DELIVERING CORRECTLY. SHE REPORTED THAT THE PATIENT WOULD HAVE ELEVATED BG AFTER BOLUSING FOR A MEAL. THE FAMILY MEMBER ALSO REPORTED THAT THE PUMP WOULD LOAD CORRECTLY AND INDICATE THE CORRECT AMOUNT OF INSULIN BUT THE PRIME STEP DID NOT SEEM TO PRIME. SHE REPORTED THAT THE PUMP WOULD RECORD AS IF PRIMING BUT NOTHING WOULD COME OUT OF THE PUMP. SHE REPORTED THAT SHE WOULD REPRIME AN ADDITIONAL 20-30 UNITS TO SEE DROPS FROM THE TUBING AND THE INSULIN REMAINING AMOUNT ABOUT WOULD BE INCORRECT. THE FAMILY MEMBER DID NOT HAVE THE PUMP AT THE TIME OF THE CALL TO COMPLETE TROUBLESHOOTING. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention