BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3232074 · Received July 17, 2013

    Report

    Report Number
    2531779-2013-11103
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 16, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 10/02/2013 ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/11/2013 WITH THE FOLLOWING FINDINGS: THE PUMP BLACK BOX HISTORY SHOWED THAT THE PUMP EMITTED A ¿REPLACE CARTRIDGE¿ ALARM ON 06/16/2013; THE PUMP DELIVERY WAS NOT RESUMED FOR 4 HOURS. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. A ¿REPLACE CARTRIDGE¿ WAS INDUCED DURING TESTING AND THE PUMP EMITTED THE APPROPRIATE VIBRATORY ALARM. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE DISCOLORED; THE DISPLAY SCREEN WAS REPLACED WITH A TEST SCREEN AND THE DISPLAY RETURNED TO NORMAL.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE PATIENT CONTACTED ANIMAS REPORTING ONGOING ISSUES WITH ELEVATED BLOOD GLUCOSE (BG) AND STATED THAT SHE DOES NOT THINK THE PUMP IS WORKING. THE PATIENT STATED THAT ON (B)(6) 2013 HER BG WAS OVER 600 MG/DL WITH NO SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE PATIENT STATED THAT ON (B)(6) 2013 HER BG ELEVATED TO 547 MG/DL PRIOR TO CALLING ANIMAS, AND AT THE TIME OF THE CALL THE PATIENT REPORTED HER BG TO BE 370 MG/DL. THERE WERE NO REPORTED SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE PATIENT STATED SHE HAS BEEN EXPERIENCING ELEVATED BGS SINCE (B)(6) 2013. THE PATIENT STATED THAT ON (B)(6) 2013 SHE CHANGED HER SITE IN RESPONSE TO ELEVATED BG. THE PATIENT REPORTEDLY BOLUSES PER PUMP RECOMMENDATIONS. THE PATIENT STATED THAT ON (B)(6) 2013 SHE TOOK A CORRECT INJECTION FOR ELEVATED BG. THE PATIENT NOTED THAT NORMALLY THE AMOUNT OF INSULIN SHE GAVE VIA INJECTION WOULD BRING HER BG DOWN TO AROUND 150 MG/DL, BUT HER BG HAD ONLY COME DOWN TO 370 MG/DL FROM 574 MG/DL. THE PATIENT STATED THAT DUE TO INSURANCE ISSUES SHE HAD TO SWITCH FROM NOVOLOG INSULIN TO HUMALOG INSULIN IN (B)(6) 2013, WHICH CORRESPONDS TO WHEN HER BG ISSUES BEGAN. THE PATIENT ALSO NOTED THAT ON (B)(6) 2013 SHE WENT TO SEE A SURGEON FOR A THUMB INJURY AND WAS GIVEN INJECTIONS WITH LIDOCAINE, BUT WAS UNSURE OF THE SPECIFIC NAME OF THE MEDICATION. THE PATIENT NOTED STRESS DUE TO THE APPOINTMENT, BUT NO OTHER STRESS TO ACCOUNT FOR CONTINUED BG ELEVATIONS. THE PATIENT STATED THAT SHE HAS CALLED PREVIOUSLY AND REVIEWED THE PUMP; THE PATIENT STATED NO SETTINGS CHANGES HAVE BEEN MADE SINCE SHE LAST SAW HER HEALTHCARE PROVIDER (HCP) IN (B)(6) 2013. CUSTOMER TECHNICAL SUPPORT REVIEWED THE PUMP WITH THE PATIENT AND FOUND ALL SETTINGS AND HISTORIES ARE CORRECT. THE PATIENT REPORTEDLY SPOKE WITH HER HCP ON (B)(6) 2013 AND HAS AN APPOINTMENT WITH HER HCP ON (B)(6) 2013. THE PATIENT STATED THAT SHE HAS LOST FAITH IN THE PUMP, AND THE PATIENT¿S HCP REQUESTED THE PUMP BE REPLACED. THERE WAS NO INDICATION OF A PUMP DEFECT FOUND UPON TROUBLESHOOTING. HOWEVER THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED MULTIPLE INCIDENTS OF HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY, AND BASED ON THE ALLEGATION BY THE PATIENT AND THE HCP THAT THE PUMP WAS NOT WORKING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331438 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening