BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1921923 · Received December 6, 2010

    Report

    Report Number
    2531779-2010-02697
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 5, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PUMP OR INFUSION SITE ISSUES RELATED TO THE HOSPITALIZATION WERE DISCOVERED DURING REVIEW WITH THE FAMILY MEMBER. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS ADMITTED TO THE HOSPITAL WITH ELEVATED BLOOD GLUCOSE (487 MG/DL) AND DKA. A FAMILY MEMBER REPORTED THAT THE PT WOKE UP AT 5:30 AM WITH ELEVATED BLOOD GLUCOSE (NO ACTUAL VALUE AVAILABLE). BY 6:00 AM, HE WAS VOMITING AND HAD CHEST PAIN; HE WAS TAKEN TO THE ER. CARDIAC AND INFECTION TESTING WAS NEGATIVE. BLOOD GLUCOSE RESOLVED TO 114 MG/DL AFTER TREATMENT WITH INTRAVENOUS INSULIN IV INSULIN. ON THE DAY OF THE EVENT, HE RECEIVED A REPLACE BATTERY ALARM AT 2:34 AM AND THE BATTERY WAS NOT REPLACED UNTIL 6:30 AM BY THE FAMILY MEMBER. FURTHER ASSESSMENT WITH THE FAMILY MEMBER REVEALED THAT THE PT'S BLOOD GLUCOSE HAD BEEN GREATER THAN 200 MG/DL DURING THE PAST MONTH. REVIEW OF THE PUMP HISTORY SHOWED THAT THE PT HAD A REPLACE BATTERY ALARM ON (B)(6) 2010 AT 3:23 AM AND DID NOT REPLACE IT UNTIL 9:17 PM THE SAME DAY. ON SEVERAL DAYS IN (B)(6), THE BASAL DELIVERY WAS LOW SECONDARY TO LACK OF APPROPRIATE BATTERY REPLACEMENT. THE HISTORY ON MULTIPLE DAYS REVEALED AN ABSENCE OR LOW AMOUNTS OF BOLUSES. THE FAMILY MEMBER STATED THAT THE PT EATS SPORADICALLY SO THAT MIGHT EXPLAIN THE LACK OF BOLUS DELIVERIES; SHE DID NOT DENY THAT THE PT FORGOT TO REPLACE THE BATTERIES AND SHE NOTED THAT THE PT'S PHYSICIAN TOLD HER THAT ADJUSTMENTS TO THE BASAL RATES WERE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization