BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2122361 · Received June 13, 2011

    Report

    Report Number
    2531779-2011-04097
    Event Type
    Injury
    Date Received
    June 13, 2011
    Report Date
    May 14, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: PUMP SETTINGS INDICATE ALERT SOUND SET TO 'H' (HIGH) DURING INVESTIGATION. THE PUMP ALERTS WITH AUDITORY AND VIBRATORY ALARMS. THE TOTAL DAILY DOSE HISTORY WAS REVIEWED FROM (B)(6) 2011 TO END OF PUMP USE ON (B)(6) 2011. THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. PUMP ACCURATELY DELIVERS 2.00 UNITS/HR FOR 29-HR PERIOD. THERE WAS NO DELIVERY RELATED MALFUNCTIONS OBSERVED DURING INVESTIGATION. UNRELATED TO THE COMPLAINT, THE UP BUTTON WAS TORN AND OK BUTTON WAS PEELING ON THE KEYPAD. THERE WAS CONTAMINATION FOUND UNDER THE KEYPAD. IN ADDITION THE UP BUTTON CONTACT WAS MISALIGNED. 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

    THE REPORTER CLAIMED THAT HER BLOOD GLUCOSE HAS BEEN RUNNING FROM 200-564 MG/DL FOR (B)(6) WHILE THE PATIENT HAS BEEN MANAGING HER DIABETES WITH THE ANIMAS PUMP. REPORTEDLY, HER DOCTOR INCREASED HER BASAL INSULIN RATE ON 3 OCCASIONS IN ATTEMPTS TO LOWER HER HYPERGLYCEMIA. HER CURRENT BLOOD GLUCOSE IS AT 313 MG/DL. SHE HAS SYMPTOMS OF NAUSEA AND SMALL KETONES. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE NOTED THE FOLLOWING: THE PATIENT ROTATES HER INSULIN SITE ON THE ABDOMEN EVERY 2-3 DAYS. THERE WERE NO BUBBLES IN THE TUBE OR DIFFICULTY WITH INSERTION CARTRIDGE INFUSION SET. THE ADVANCED FEATURES SUCH AS INSULIN TO CARBOHYDRATE RATIO, INSULIN SENSITIVITY FACT, TARGET, AND INSULIN ON BOARD WERE SET CORRECTLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD HIGH BLOOD GLUCOSE OVER 500 MG/DL WHILE SHE MANAGED HER DIABETES WITH THE ANIMAS INSULIN PUMP.

    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 18 YR Life Threatening| R