BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1976264 · Received January 26, 2011

    Report

    Report Number
    2531779-2011-00458
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP AND ASSOCIATED CARTRIDGE HAVE BEEN RETURNED TO ANIMAS FOR EVAL. THE EVAL OF THE PRODUCTS HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVAL IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. ASSOCIATED PRODUCT LABELED FOR SINGLE: CARTRIDGE LOT# B201528.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT CONTACTED ANIMAS ALLEGING ELEVATED BLOOD GLUCOSE (BG) LEVELS AND REPEATED OCCLUSION ALARMS. THE PT INDICATED THAT SHE HAD BEEN RECEIVING OCCLUSION ALARMS APPROXIMATELY EVERY 2 HOURS FOR PREVIOUS 5 DAYS. THE PT CLAIMED THAT THE OCCLUSION ALARMS WOULD NOT OCCUR DURING BOLUSING OF INSULIN. SHE CLAIMED THAT THE OCCLUSION ALARMS WOULD OCCUR DURING BASAL DELIVERY. THE PT DENIED HAVING SYMPTOMS OF NAUSEA, VOMITING, SHORTNESS OF BREATH, AND ABDOMINAL PAIN. HOWEVER, THE PT INDICATED THAT SHE HAD GOTTEN "HIGH" RESULT ON HER METER. ACCORDING TO THE OWNER'S MANUAL, A "HIGH" RESULT INDICATES A POSSIBLE BG LEVEL EXCEEDING 600 MG/DL MIGHT HAVE BEEN DETECTED. THROUGH TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE CONFIRMED THAT THE PT DISCONNECTED FROM THE PUMP, AND REMOVED THE CARTRIDGE. THE PT MANUALLY PRIMED THE TUBING AND CARTRIDGE. SHE STATED INSULIN FLOWED EASILY OUT OF TUBING WHEN PUSHING ON PLUNGER. NO USUAL MOTOR SOUNDS WERE OBSERVED WHEN PRIMING. THE CARTRIDGES AND SETS WERE WITHIN EXPIRATION DATE. THE PT ADMITTED TO HAVING SCAR TISSUE AT HER SITE. HOWEVER, SHE CLAIMED THAT SHE WAS ROTATING SITE AND AVOIDING THE SCAR TISSUE. SHE ALSO DENIED OBSERVING A BENT CANNULA. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT SHE OBTAINED ELEVATED BG READINGS WHICH CAN BE ASSOCIATED WITH A SERIOUS INJURY. THE ALLEGED PRODUCT ISSUE IS NOT LIKELY TO CAUSE AN ADVERSE EVENT BECAUSE THE PUMP WILL ALARM TO ALERT THE USER OF THE ISSUE. THE OWNER'S BOOKLET INSTRUCTS THE USER TO BE PREPARED TO GIVE HIS OR HERSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON.

    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 53 YR