BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2220825 · Received August 23, 2011

    Report

    Report Number
    2531779-2011-06140
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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 PUMP HISTORY INDICATED THAT THE YEAR WAS INCORRECTLY SET TO 2012 THROUGHOUT THE PUMP HISTORY. PER THE PUMP HISTORY, INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO INSULIN DELIVERY DEFECTS FOUND; THE PUMP WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. A REVIEW OF THE PUMP'S BLACK BOX INDICATED A "LOW BATTERY" WARNING OCCURRED AT 11:02 AM ON "(B)(6) 2012", AND A "REPLACE BATTERY" ALARM OCCURRED AT 5:21 PM ON THE SAME DATE. THE PUMP HISTORY SHOWS THAT THE PUMP WAS NOT RESUMED FOLLOWING THE "REPLACE BATTERY" ALARM UNTIL (B)(6) AT 11:34 PM. THE PUMP ELECTRICAL CURRENT DRAWS WERE TESTED AND WERE WITHIN SPECIFICATIONS. DURING TESTING A "LOW BATTERY" WARNING AND A "REPLACE BATTERY" ALARM WERE DUPLICATED, AND THE PUMP EMITTED THE APPROPRIATE AUDIOVISUAL ALERTS. THERE WAS NO DEFECT FOUND ON INVESTIGATION.

    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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2011 WITH ELEVATED BLOOD GLUCOSE LEVELS (1100MG/DL). THE PATIENT REPORTS THAT ON (B)(6) 2011 SHE HAD GONE FOR DIALYSIS AND SHE ADJUSTED HER BASAL RATES FOR THE SUGAR USED DURING THE PROCESS. THE PATIENT INDICATED THAT HER BLOOD GLUCOSE (BG) LEVELS ON 7/20 WERE OK, BUT DOES NOT RECALL HER BLOOD GLUCOSE LEVELS BEFORE GOING TO BED. THE PATIENT REPORTS THAT HER BG LEVELS WERE RUNNING HIGH; SHE WAS GIVING HERSELF INSULIN, BUT DID NOT CHECK HER BG LEVEL UNTIL IT WAS TOO LATE AND ENDED UP PASSING OUT. THE PATIENT PASSED OUT AT HOME AND HER STEP SON CALLED 911. THE PATIENT WAS TAKEN TO THE HOSPITAL VIA AMBULANCE. THE PATIENT WAS ADMITTED TO THE ICU. THE PATIENT REPORTS WHILE IN THE AMBULANCE HER BG WAS CHECKED AND IT WAS "HI". AT THE HOSPITAL SHE WAS TOLD THAT HER BG WAS 1100MG/DL. THE PATIENT WOKE UP IN THE ICU ON (B)(6), THE SAME DAYS AS GOING TO HOSPITAL. THE PATIENT THINKS SHE WAS TAKEN TO THE HOSPITAL IN THE EARLY MORNING, BUT IS NOT SURE OF THE TIME. THE PATIENT INDICATED THAT WHILE IN THE HOSPITAL SHE GOT AN INFECTION. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) AND STARTED BACK ON THE PUMP. THE PATIENT'S BLOOD GLUCOSE ROSE TO 483 MG/DL, AND THE PATIENT DISCONTINUED USE OF THE PUMP.

    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 30 YR Hospitalization