BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1971426 · Received January 13, 2011

    Report

    Report Number
    2531779-2011-00292
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/02/2013 WITH THE FOLLOWING FINDINGS: THERE WAS NO DATA IN THE PUMP BLACK BOX RELATED TO THE COMPLAINT DUE TO CONTINUED PATIENT USE. A REVIEW OF THE TOTAL DAILY DOSE HISTORY FOR THE AVAILABLE DATE RANGE SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE REPORTER (AN ANIMAS REP) CONTACTED ANIMAS AND REPORTED THAT A PATIENT WENT TO AN EMERGENCY ROOM (ER) ON (B)(6) 2010, WITH "SEVERE HYPOGLYCEMIA". AT THAT TIME, THE PT WAS REPORTEDLY PREGNANT AND SICK WITH GI ISSUES. THE REPORTER NOTED THAT THE PATIENT HAS A HISTORY OF FREQUENT SEVERE HYPOGLYCEMIA EPISODES WITH MONTHLY ER VISITS. THE REPORTER NOTED THAT SHE EVEN HAD THE FREQUENT EPISODES PRIOR TO USING THE PUMP. ON (B)(6) 2010, THE REPORTER CONTACTED ANIMAS AGAIN AND INDICATED THAT THE PATIENT HAD ANOTHER VISIT TO THE ER ON (B)(6) 2010, DUE TO HYPOGLYCEMIA. AT AN UNSPECIFIED TIME THAT DAY, THE PT REPORTEDLY WOKE UP WITH A BLOOD GLUCOSE (BG) LEVEL IN THE "90'S" MG/DL. THE PT ATE BREAKFAST AND BOLUSED. AFTER BREAKFAST, THE PT'S BG LEVEL WAS AT "128 MG/DL". AT ANOTHER UNSPECIFIED TIME THAT DAY, THE PT CLEANED A HOUSE AND THEN TOOK A NAP. THE PT REPORTEDLY WOKE UP IN AN AMBULANCE WITH A BG LEVEL OF "17 MG/DL". ON (B)(6) 2010, THE PATIENT'S DOCTOR CONTACTED AN ANIMAS CDE AND INFORMED HER THAT THE PATIENT WAS REMOVED FROM THE PUMP. SEVERAL ATTEMPTS WERE MADE UNSUCCESSFULLY TO CONTACT THE PT FOR F/U INFO. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER INDICATED THAT THE PATIENT WAS TAKEN TO THE ER ON TWO SEPARATE OCCASIONS FOR SEVERE HYPOGLYCEMIA. THE PT ALSO REPORTEDLY HAD A BG LEVEL OF "17 MG/DL." THERE IS NO EVIDENCE, HOWEVER, AT THIS TIME THAT THE PUMP WAS WORKING IMPROPERLY.

    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 38 YR Hospitalization| L