BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2842702 · Received November 21, 2012

    Report

    Report Number
    2531779-2012-13849
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS 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 BLACK BOX REVIEW CONFIRMS THAT THE PUMP IS OUT OF BOX AND IT WAS NEVER USED FOR BASAL DELIVERIES, NO BLACK BOX OR HISTORY RECORDS AVAILABLE. THE PUMP POWERS UP NORMALLY, EZ-PRIME STEPS WERE PERFORMED SUCCESSFULLY. THE PUMP WAS EXERCISED FOR 24 HOURS, NO ALARMS OCCURRED DURING TESTING. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED ON THE PUMP AND THE PUMP PASSED THE TEST AND IT WAS FOUND TO BE DELIVERING WITH THE REQUIRED SPECIFICATIONS. THE PUMP'S COVER WAS REMOVED AND THERE WAS NO EVIDENCE OF MOISTURE OBSERVED. THE PCB AND FLEXES WERE TESTED FOR INTERMITTENT CONDITION; NONE WAS FOUND. THERE WAS NO DEFECT FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER (PATIENT'S MOM) CONTACTED ANIMAS REPORTING THAT THE PATIENT HAD A HIGH BLOOD GLUCOSE LEVEL BEFORE BED LAST EVENING (306MG/DL) AND WHEN PATIENT WOKE UP THIS MORNING PATIENT WAS 370MG/DL AND WAS SPILLING MODERATE KETONES AND WAS COMPLAINING ABOUT A BELLY ACHE. THE REPORTER REPORTED NO NEW MEDICATIONS, NO NEW ACTIVITIES/STRESSORS, NO NEW DIET CHANGES REPORTED. THE REPORTER CONFIRMED THAT THE PUMP SETTINGS (DATE/TIME, ADVANCED FEATURES) AND INSULIN TOTALS WERE CORRECT AND THE PUMP HISTORY APPEARED TO BE APPROPRIATE: IT DID NOT INDICATE ANY PUMP MALFUNCTION. THE INSULIN WAS STORED APPROPRIATELY AND WAS WITHIN EXPIRATION DATE. THE PATIENT REPORTEDLY DID NOT HAVE ANY ISSUES WITH THE INFUSION SITE/SET (NO BUMPS, NO BRUISING, NO BLEEDING OR LEAKING AT SITE AND NO BENT CANNULA). THE REPORTER ALSO STATED THAT THE PATIENT ROTATES INFUSION SITES BETWEEN ABDOMEN AND LEGS. WHEN ASKED IF THERE COULD BE ANY OTHER FACTORS CONTRIBUTING TO THE PATIENT'S BLOOD GLUCOSE LEVELS, THE REPORTED STATED THAT THE PATIENT HAD GROWN 1.5 INCHES IN THE LAST 2 MONTHS. THE PATIENT CONTINUED TO USE THE PUMP DURING THE REPORTED INCIDENT AND REPORTEDLY DID NOT RECEIVE ANY OTHER FORMS OF TREATMENT. THERE WAS NO INDICATION THAT THE PUMP MALFUNCTIONED BASED ON ANIMAS CUSTOMER SUPPORT TROUBLESHOOTING. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED INJURIES THAT MET ANIMAS' CRITERIA OF A SERIOUS INJURY WHILE USING THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Life Threatening| R