BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1944349 · Received December 15, 2010

    Report

    Report Number
    2531779-2010-02893
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER DENIED THAT THERE WAS A BENT CANNULA WITH SITE REMOVED. SHE ALSO DENIED OBSERVING AIR BUBBLES, LEAKS, OR SMELL OF INSULIN. THE REPORTER CLAIMED THAT SHE WAS USING THE SAME INSULIN USED WITH THE INJECTORS THAT HELPED TO LOWER THE PT'S BLOOD GLUCOSE LEVELS. THE REPORTER ALSO CLAIMED THAT SHE CHANGED INSULIN TO RULE THE INSULIN OUT. SHE ALSO CLAIMED THAT THE INSULIN WAS AT ROOM TEMP. THE REPORTER MENTIONED THAT THE PT ROTATES ON THE ABDOMEN AND DENIED LUMPINESS OR HARDNESS TO THE AREA. THE REPORTER ALSO DENIED ANY PROBLEMS INSERTING INSETS AND APPEARED TO BE INSERTING CORRECTLY. A REVIEW OF THE PUMP REVEALED THAT THE TIME/DATE WERE CORRECT. THE BASAL PROGRAM WAS CONFIRMED TO BE CORRECT AND ADDED UP TO THE TDD. NO ASSOCIATED ALARMS WERE NOTED IN THE HISTORY. THE REPORTER WAS PRIMING AND FILLING APPROPRIATELY. THE REPORTER WAS ADVISED TO REVIEW SITE ROTATION WITH THE PT'S DOCTOR IF A REPLACEMENT PUMP DID NOT RESOLVE THE ALLEGED ISSUE. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6), 2010, ALLEGING UNEXPLAINED BLOOD GLUCOSE (BG) ELEVATIONS. THE REPORTER CONTACTED ANIMAS ON BEHALF OF HER DAUGHTER (THE PT). THE REPORTER CLAIMED THAT FOR THE PAST 2 MORNINGS, THE PT HAD BLOOD GLUCOSE LEVELS OF "509 MG/DL" WITH SYMPTOMS OF NAUSEA AND VOMITING. THE REPORTER ALSO CLAIMED THAT THE PT TESTED POSITIVE FOR KETONES ON (B)(6) 2010, BUT DENIED THAT THE PT HAD SHORTNESS OF BREATH. THE PT WAS REPORTEDLY GIVEN AN INJECTION RESULTING WITH A BLOOD GLUCOSE LEVEL OF "103 MG/DL." THE SITE WAS REPORTEDLY CHANGED AND THE BLOOD GLUCOSE LEVEL WAS ALLEGEDLY ELEVATED BACK UP TO "324 MG/DL." ANOTHER INJECTION WAS GIVEN WHICH BROUGHT THE PT'S BLOOD GLUCOSE LEVEL DOWN TO AN UNSPECIFIED LEVEL. HOWEVER, THE BLOOD GLUCOSE LEVEL ALLEGEDLY WENT BACK UP TO "390 MG/DL" WITH THE PUMP. ON (B)(6) 2010, THE PT'S BLOOD GLUCOSE LEVEL WENT DOWN TO "94 AND 114 MG/DL" WITH INJECTION(S). AFTER GOING BACK ON THE PUMP, THE REPORTER CLAIMED THAT THE PT'S BLOOD GLUCOSE WENT BACK UP TO "430 MG/DL." ALSO ON (B)(6) 2010, THE REPORTER CLAIMED THAT SHE CHANGED THE INSULIN AND THE SITE AND THE PT'S BLOOD GLUCOSE WAS AT 230 MG/DL (8 PM) AND 288 MG/DL (9 PM) AFTER A BOLUS. BY 9:30 PM, THE PT'S BLOOD GLUCOSE WAS AT 300 MG/DL WITH KETONES. THE REPORTER DISCONNECTED THAT PT FROM THE PUMP AND STARTED A SYRINGE. THE PT'S BLOOD GLUCOSE WENT DOWN TO 119 MG/DL WITH INJECTION. THE REPORTER DENIED THAT THE PT WAS ILL OR ON ANY NEW MEDICATIONS. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PT DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH A SERIOUS INJURY WHILE USING THE REPORTER DEVICE.

    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 16 YR Life Threatening