BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2862468 · Received December 10, 2012

    Report

    Report Number
    2531779-2012-14325
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    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

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/08/2013 WITH THE FOLLOWING FINDINGS:. DAILY INSULIN DELIVERY TOTALS APPEAR INCONGRUENT DUE TO TIME AND DATE ISSUE. BLACK BOX SHOWS TIME AND DATE RESETTING TO DEFAULT FOLLOWING A POR AT 6:49PM (B)(6) 2013; THE TIME WAS THEN MANUALLY SET TO 6:48PM (B)(6) 2012. NO DATA IN BLACK BOX OR DOWNLOAD HISTORIES FROM TIME OF REPORTED HOSPITALIZATION DUE TO CONTINUED USE. MOISTURE VISIBLE IN DISPLAY. DURING DURATION TESTING PUMP GIVES CALL SERVICE 088 ALARM. UNABLE TO PERFORM STEPS 22 AND 23 DUE TO RECURRING ALARM. BATTERY COMPARTMENT IS CRACKED. LEAK TEST VERIFIES LEAK IN BATTERY COMPARTMENT. PUMP OPENED AND MOISTURE DAMAGE FOUND ON THE PCB. THE INTERNAL BATTERY (BT1) FOUND TO BE LEAKING.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 REPORTING THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR BLOOD GLUCOSE (BG) LEVELS OF 400-500MG/DL WITH LARGE KETONES AND VOMITING. THE PATIENT WAS TREATED IN THE HOSPITAL WITH INSULIN VIA SYRINGE AND ALSO BASAL TREATMENT FROM THE PUMP. THE REPORTER STATED THAT THE PATIENT WAS TREATED AT HOME VIA SYRINGE AND DID NOT SEE IMPROVEMENT. THE REPORTER STATED THAT THE INSETS WERE CHANGED EIGHT TO TEN TIMES, THE INSETS DID NOT HAVE BENT CANNULAS OR ANYTHING UNUSUAL SEEN AT THE SITE/SET. TROUBLESHOOTING INDICATED THAT ALL BASAL RATES WERE CORRECT AND HAVE BEEN ADJUSTED BY THE HEALTHCARE PROFESSIONAL. HISTORY WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE BOLUS HISTORY AND TOTAL DAILY DOSE WERE CORRECT AND REFLECT APPROPRIATE AMOUNTS GIVEN. CUSTOMER SUPPORT CONFIRMED WITH REPORTER THAT THERE IS NO MALFUNCTION WITH THE PUMP. THE REPORTER WILL FOLLOW-UP WITH THE HEALTHCARE PROFESSIONAL FOR FURTHER EVALUATION OF THE SETTINGS. THE REPORTER MENTIONED THAT THE PATIENT IS HAVING GROWTH SPURTS AND HORMONAL CHANGES. ALTHOUGH NO SPECIFIC EVIDENCE OF PUMP MALFUNCTION, DEFECT, OR MISUSE WAS DETECTED, THIS REPORT IS BEING MADE DUE TO THE POSSIBILITY THAT THE USE OF AN INSULIN PUMP MAY HAVE CONTRIBUTED IN AN UNIDENTIFIED MANNER TO THE BLOOD GLUCOSE INCIDENT.

    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 Hospitalization