BEUDAMED
    FDA Adverse Event Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3200950 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09458
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/28/2014 WITH THE FOLLOWING FINDINGS: UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. NO DEFECT WAS FOUND. THE BLACK BOX BEGINS ON (B)(6) 2013. THE PUMP WAS USED AFTER THE ORIGINAL COMPLAINT DATE (B)(6) 2013 AND ALL HISTORIES AND BLACK BOX DATA FOR EVENT HAVE BEEN OVERWRITTEN. THE CURRENT BLACK BOX AND ALARM HISTORY SHOWS ONLY TYPICAL USAGE ALARMS. THE TDD¿S ADD UP CORRECTLY AND REFLECT THE USER'S PROGRAMMED BASAL RATES..PUMP SUCCESSFULLY PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS NO ALARMS OCCURRED DURING TESTING. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: BLOOD GLUCOSE (BG) OF OVER 600 MG/DL AT TIME OF CALL. NO SPECIFIC SYMPTOMS REPORTED, BUT STATED THAT HE WASN'T FEELING TOO WELL. LATER DURING CALL HE REPORTED BEING DOWN TO 535 MG/DL AND BY END OF CALL WAS 504 MG/DL. REVIEWED BOLUS HISTORY WITH WIFE BECAUSE PATIENT IS LEGALLY BLIND AND IS UNABLE TO READ DISPLAY CLEARLY. BOLUSES BETWEEN 6:30 PM AND 8:40 PM ALL SHOW AS COMPLETED, BUT THERE IS A GAP BETWEEN 7:57 AM AND 6:31 PM WHERE THERE ARE NO BOLUSES SHOWING AT ALL. PATIENT FEELS THAT HE MAY HAVE NOT DELIVERED ALTHOUGH HE ATTEMPTED, BUT HE DOES BOLUSES BY SOUND ONLY (LISTENS TO VIBRATIONS) AND SOMETIMES DOESN'T DELIVER THEM. HE WAS OUT TO LUNCH TODAY AND THOUGHT HE HAD GIVEN A BOLUS. TDD REVIEWED AND APPEARS CORRECT. PATIENT FEELS THAT THE ISSUE IS WITH HIM NOT DELIVERING BOLUSES EACH TIME THAT HE ATTEMPTS BECAUSE HE GOES ONLY BY THE SOUNDS OF THE DELIVERY AND CANNOT VERIFY ANYTHING ON THE DISPLAY. HE ALSO FEELS THAT SOMETIMES HE ACCIDENTALLY CANCELS BOLUSES WHEN HE GOES TO PUT PUMP BACK ON HIS BELT AND DOESN'T REALIZE IT. EDUCATED ON AUDIO BOLUS FEATURE AND INSTRUCTED TO HAVE WIFE AND DAUGHTER READ ABOUT IT IN MANUAL. DAUGHTER IS AN MD AND HE WILL DISCUSS WITH HER. PATIENT AND WIFE ARE NOT BLAMING PUMP, BUT FEEL THAT ISSUE MAY BE WITH PATIENT'S INABILITY TO SEE DISPLAY AND VERIFY BOLUS DELIVERY. PATIENT AGREES TO MONITOR BG TONIGHT AND CALL BACK IF ANY ISSUES. THIS COMPLAINT IS BEING REPORTED BECAUSE A PATIENT ON PUMP THERAPY EXPERIENCED HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301660 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening