BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3102527 · Received May 9, 2013

    Report

    Report Number
    2531779-2013-06091
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/01/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, A REVIEW OF THE PUMP HISTORY SHOWED DATES BEGINNING ON (B)(6) 2013. DATA FOR THE EVENT ON (B)(6) 2013 HAS BEEN WRITTEN OVER IN BOTH THE HISTORY AND BLACK BOX DUE TO CONTINUED USE OF THE PUMP. THE CURRENT PUMP HISTORY SHOWED NO ALARMS OUTSIDE THE RANGE OF NORMAL PATIENT USE. THE BASAL AND BOLUSES ADDED UP APPROPRIATELY TO TOTAL THE TOTAL DAILY DOSE UNITS REMAINING WERE CORRECTLY CALCULATED AND WRITTEN TO THE PUMP HISTORY. THE PUMP PASSED A 29 HOUR FLOW ACCURACY TEST SUCCESSFULLY. THE COMPLAINT WAS NOT ABLE TO BE DUPLICATED BECAUSE THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING LOW BLOOD GLUCOSE (BG) ON (B)(6) 2013 OF 49 MG/DL AT 8:00 PM. THE PATIENT REPORTED TREATING THE HYPOGLYCEMIA WITH ORANGE JUICE AND THE BG RESPONDED BY ELEVATING TO 100 MG/DL. THE PATIENT REPORTED THAT TWO HOURS LATER, HIS BG WAS BACK DOWN TO 39 MG/DL. THE PATIENT REPORTED TREATING FOR THE HYPOGLYCEMIA AGAIN AND THEN WENT TO SLEEP. THE PATIENT REPORTED WAKING ON (B)(6) 2013 AT 4:30 AM WITH THE REMOTE METER IN HIS HAND AND "DID NOT KNOW HOW HE GOT UP WITH METER". THE PATIENT REPORTED HIS LOW BG WAS <39 MG/DL. THE PATIENT REPORTED, HE WAS NOT ABLE TO FIND HIS GLUCOSE TABLETS, AND HIS BG WENT EVEN LOWER (UNSPECIFIED MEASUREMENT). THE REPORTER STATED, HE DRANK DR. PEPPER AND TREATED HIMSELF WITH GLUCAGON, AS HIS WIFE WAS UNAVAILABLE TO ASSIST. THE PATIENT REPORTED THAT HE ATE A REECE'S CUP AND HIS BG MEASURED 60 MG/DL AFTER THE INJECTION. THE PATIENT REPORTED CONSUMING 10 OUNCES OF ORANGE JUICE AND HIS BG MEASURED 120 MG/DL. THE REPORTER STATED THAT THIS SAME SCENARIO HAPPENED ON (B)(6) 2013 ALSO; HOWEVER, HIS WIFE WAS HOME AT THAT TIME AND MADE SURE HE HAD JUICE AND HIS BG RESPONDED INTO TARGET RANGE. THE PATIENT COMMENTED THAT HIS HEALTHCARE PROVIDER BELIEVES THAT THE PATIENT'S HISTORY OF EXPOSURE TO "AGENT ORANGE" MAY CAUSE HIM TO CONTINUE TO MAKE INSULIN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED LOW BG WHILE ON INSULIN PUMP THERAPY AND THERE WAS NOT ENOUGH INFORMATION AVAILABLE AT THE TIME TO RULE OUT A PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204273 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR