BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3223575 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10503
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/16/2013 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. MULTIPLE OCCLUSION ALARMS OBSERVED IN THE BLACK BOX; HIGH FORCE OBSERVED. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. REWIND, LOAD CARTRIDGE, AND PRIME STEPS PERFORMED SUCCESSFULLY WITH NO ALARMS. A FORCE SENSOR CALIBRATION TEST CONFIRMED THE SENSOR IS DETECTING CORRECT FORCE AT 5LBS. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. NO PRIME ISSUES OR OCCLUSIONS OCCURRED DURING TESTING. AN OCCLUSION WAS INDUCED AND THE PUMP GIVES THE APPROPRIATE VISUAL AND AUDIBLE "OCCLUSION DETECTED" ALARM. 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.

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE OF BEING UNABLE TO PRIME IS DETECTED BY THE USER. THE OWNER¿S BOOKLET INSTRUCTS THE USER TO PRIME THE PUMP UNTIL DROPS OF INSULIN APPEAR AT THE END OF THE TUBING. THE ALLEGED MALFUNCTION IS NOT LIKELY TO CAUSE AN ADVERSE EVENT AS IT CREATES A SITUATION WHERE THE PUMP CANNOT BE ADEQUATELY PREPARED FOR INSULIN DELIVERY. 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. THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS ALLEGING THAT HE WAS EXPERIENCING ELEVATED BLOOD GLUCOSE (BG) OF 310MG/DL WITH ELEVATED BLOOD PRESSURE (BP) AND SHORTNESS OF BREATH. THE PATIENT HAD REPORTEDLY CONTACTED HIS HEALTHCARE PROVIDER (HCP), WHO INSTRUCTED HIM TO CORRECT BGS WITH AN INSULIN INJECTION AND TO GO TO THE ER IF HE DID NOT FEEL BETTER. THE PATIENT ENDED THE CALL WITH CUSTOMER TECHNICAL SUPPORT (CTS), STATING HE WAS GOING TO THE HOSPITAL. CTS FOLLOWED UP WITH THE PATIENT LATER THE SAME DAY, AND THE PATIENT STATED HE WAS ABLE TO GET HIS BG DOWN AND DID NOT GO TO THE HOSPITAL, BUT THAT HIS BG HAD ELEVATED AGAIN AS HIGH AS 375MG/DL. THE PATIENT STATED HE ALSO HAS BP ISSUES AND THAT WHEN HIS BG ELEVATES, HIS BP ELEVATES TOO. AT THE TIME OF FOLLOW-UP, THE PATIENT WAS REPORTEDLY ON INSULIN INJECTIONS TO CONTROL BGS. THE PATIENT STATED THAT HE USES U500 INSULIN IN THE PUMP, BUT DID NOT HAVE SYRINGES FOR THAT TYPE OF INSULIN SO HE WAS USING U100 INSULIN FOR INJECTIONS. THE PATIENT ALSO STATED HE HAD TAKEN AN INJECTION OF LEVEMIR, A LONG-ACTING INSULIN. THE PUMP IS NOT LABELED FOR USE WITH U500 (CONCENTRATED) INSULIN, THEREFORE THIS CONSTITUTES MISUSE OF THE PUMP. THE PATIENT NOTED THAT HE HAD ATTEMPTED TO PERFORM EZPRIME STEPS AND THE PUMP WOULD NOT LOAD THE CARTRIDGE OR PRIME. THE PATIENT STATED HE TAKES FOUR DIFFERENT BP MEDICATIONS AS WELL AS USES A CLONIDINE PATCH. THE PATIENT HAS A HISTORY OF HEART ATTACKS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED SEVERE HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY, AND IT IS UNCLEAR AT THIS TIME IF THE REPORTED ISSUE WITH PRIMING THE PUMP WAS A CAUSE OR CONTRIBUTOR IN THE REPORTED BG EXCURSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324276 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening