BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2823304 · Received November 7, 2012

    Report

    Report Number
    2531779-2012-13255
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    October 11, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. 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. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2012 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWS NO EVIDENCE OF 0 UNIT BOLUSES BEING PROGRAMMED OR DELIVERED ON THE REPORTED EVENT DATE. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO DELIVERY ISSUES AND NO UNPROGRAMMED BOLUSES OCCURRING. A NORMAL 10 UNIT BOLUS AND A 10 UNIT AUDIO BOLUS WERE SUCCESSFULLY PERFORMED AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. THE KEYPAD BUTTONS WERE TESTED AND THERE WAS NO HYPERSENSITIVITY OBSERVED. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THAT THE FORCE SENSOR IS OUT OF CALIBRATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CLAIMED THAT THE ANIMAS PUMP IS NOT DISPENSING INSULIN WHEN A BOLUS DOSE IS PROGRAMMED. ON THE DAY OF THE CALL, THE SCHOOL NURSE ADMINISTERED TWO BOLUS DOSES, ONE AT 11:45AM OF 1.25UNITS AND ONE AT 2:30PM OF 3 UNITS. ON BOTH OCCASION, THE PUMP HISTORY RECORDED ZERO UNIT OF INSULIN DELIVERY. SUBSEQUENTLY, THE PATIENT DEVELOPED BLOOD GLUCOSE READING OF 345 MG/DL AND WAS FEELING NAUSEOUS. THERE WAS NO REPORT OF ANY REQUIRED MEDICAL INTERVENTION TO SUGGEST A SERIOUS INJURY AT THE TIME OF CONCERN. DURING TROUBLESHOOTING, THE REPORTER NOTED THERE WAS NO ALARM PRIOR TO THE REPORTED EVENT. THE PUMP DID NOT HAVE ANY POWER LOSS. THERE WAS NO PRODUCT MISUSE. THE ISSUE WAS NOT RESOLVED. THE PRODUCT WAS REPLACED AND REQUESTED BACK FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE INSULIN DISPENSING ISSUE.

    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 7 YR