BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1971428 · Received January 13, 2011

    Report

    Report Number
    2531779-2011-00304
    Event Type
    Injury
    Date Received
    January 13, 2011
    Report Date
    December 17, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE PUMP WAS EVALUATED AND FOUND TO BE DELIVERING INSULIN ACCURATELY. INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES. UNRELATED TO THE EVENT THE DISPLAY WAS FOUND TO BE DIM AND RED.

    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 CONTACTED ANIMAS ON BEHALF OF HER SON (THE PT) AND REPORTED THAT THE PT'S BLOOD GLUCOSE (BG) LEVELS WERE ELEVATED ON (B)(6) 2010. THE PT REPORTEDLY WOKE UP WITH A BG LEVEL OF "386 MG/DL" AND SYMPTOMS OF NAUSEA AND THIRST. THE REPORTER INDICATED THAT THE PT'S BG LEVEL CONTINUED TO BE ELEVATED AT 250 MG/DL ALTHOUGH THE SITE WAS CHANGED AND THE PT WAS GIVEN AN INJECTION. THE REPORTER CLAIMED THAT THEY BOLUSED BUT THE BG DID NOT RESPOND. A SCHOOL NURSE REPORTEDLY GAVE AN INJECTION WITH A BOTTLE OF INSULIN WHILE AT SCHOOL, BUT THE BG DID NOT RESPOND. THE CARTRIDGE WAS CHANGED THE EVENING OF (B)(6) 2010, WITH A NEW BOTTLE OF INSULIN. DURING THE CONTACT WITH THE ANIMAS REP, THE PATIENT'S CURRENT BG WAS 161 MG/DL. THE REPORTER STATED THAT THERE WERE AIR BUBBLES IN THE CARTRIDGE AND TUBING MANY TIMES. THE REPORTER INDICATED THAT SHE INSPECTS AND PRIMES THE TUBING TO REMOVE AIR. THE REPORTER MENTIONED THAT SHE PUSHES AIR INTO THE VIAL OF INSULIN BEFORE FILLING. THE ANIMAS REP EXPLAINED PROPER TECHNIQUE TO THE REPORTER. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED ELEVATED BG AND SYMPTOMS WHICH CAN BE ASSOCIATED WITH A SERIOUS INJURY.

    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 Life Threatening| R