BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2091362 · Received May 17, 2011

    Report

    Report Number
    2531779-2011-03453
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    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: A REVIEW OF THE PUMP TOTAL DAILY DOSE HISTORY FROM (B)(6) 2010 TO THE END OF PUMP USE ON (B)(6) 2011 SHOWS THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. THERE WERE NO ALARMS IN PUMP HISTORY INDICATING ANY MALFUNCTION. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT SHE WAS HOSPITALIZED FOR A LOW BLOOD GLUCOSE READING. THE PATIENT'S DOCTOR FEELS THE ANIMAS PUMP IS NOT CORRECTLY DELIVERING INSULIN. THE ALLEGED HYPOGLYCEMIC EPISODE OCCURRED ON (B)(6) 2011. THE PATIENT HAD A HEARTY BREAKFAST THAT MORNING, 5 GRAMS OF CARBOHYDRATE, AND TESTED AT "82 MG/DL." AT LUNCH, THE PATIENT TOOK BOLUS INSULIN FOR A BLOOD GLUCOSE READING "275 MG/DL" AND ATE 15 GRAMS OF CARBOHYDRATE. REPORTEDLY, 2 HOURS LATER, HER HUSBAND FOUND HER UNCONSCIOUS, CALLED 911, AND ATTEMPTED TO TREAT THE PATIENT WITH ORANGE JUICE. THE PARAMEDICS TESTED THE PATIENT AT 20 MG/DL AND LATER AT 39 MG/DL IN THE AMBULANCE EN ROUTE TO THE HOSPITAL. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE CHECKED ALL THE SETTINGS AND VERIFIED ALL THE INSULIN DOSAGES WERE CORRECT. THIS COMPLAINT IS BEING REPORTEDLY BECAUSE THE PATIENT REPORTEDLY HAD A HYPOGLYCEMIC EPISODE WHILE USING THE ANIMAS INSULIN PUMP TO MANAGE HER DIABETES.

    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 59 YR Hospitalization| L| R