BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2221661 · Received August 24, 2011

    Report

    Report Number
    2531779-2011-06173
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 30, 2011
    Report Date
    July 30, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT'S FRIEND/FAMILY MEMBER CONTACTED ANIMAS ON (B)(6) 2011 TO REPORT THAT THE PATIENT HAD BEEN TAKEN TO THE HOSPITAL VIA AMBULANCE AFTER HE BECAME "UNRESPONSIVE". AT THE TIME OF HIS ARRIVAL TO THE ER, THE PATIENT'S NURSE REPORTED HIS BLOOD GLUCOSE (BG) WAS 630 MG/DL. THE REPORTER STATED SHE WAS ADVISED BY DOCTOR TO CONTACT THE PUMP'S MANUFACTURER TO GET THE PUMP REPLACED. NEITHER THE REPORTER, NOR THE PATIENT'S FATHER KNEW WHAT WAS WRONG WITH THE PUMP. AT THE TIME OF THE CALL, THE PATIENT WAS AWAKE AND ANSWERING QUESTIONS. IT IS NOT KNOWN WHAT MEDICAL TREATMENT THE PATIENT RECEIVED. AT THE TIME OF TROUBLESHOOTING, THE PATIENT REPORTED THAT HIS BEDTIME BLOOD GLUCOSE ON (B)(6), 2011 WAS IN TARGET (READING NOT PROVIDED). ON THE MORNING OF (B)(6) 2011 HE WOKE UP WITH BLOOD GLUCOSE OF 500 MG/DL. IT IS NOT KNOWN IF THE PATIENT HAD SIGNS/SYMPTOMS OF A HIGH BLOOD GLUCOSE. IT IS ALSO NOT KNOWN WHAT THE PATIENT DID REGARDING HIS DIABETES MANAGEMENT IN RESPONSE TO THE HIGH BG. THE PATIENT REPORTED THAT AROUND NOON THAT DAY HIS SITE CAME OFF, BUT HE DID NOT KNOW IT. WHEN TAKEN TO THE HOSPITAL, IT WAS MENTIONED THAT THE SKIN WERE SITE CAME OFF WAS WET AND IT WAS OBSERVED THAT THE CANNULA WAS BENT. THE PATIENT REPORTED THAT HE HAD LAST CHANGED HIS SITE 3 DAYS PRIOR. THE REPORTER WAS UNABLE TO CONFIRM IF THE SETTINGS IN THE PUMP WERE PROGRAMMED CORRECTLY; HOWEVER, CONFIRMED THE PUMP'S DATE AND/OR TIME WERE INCORRECT WHEN CUSTOMER SUPPORT REQUESTED IT BE CHECKED. THE PATIENT CLAIMED HE DOES NOT CHECK THE DATE/TIME SETTINGS ON THE PUMP AND WAS UNAWARE THAT THE DATE AND/OR TIME WERE INCORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| L| R