BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2110704 · Received June 1, 2011

    Report

    Report Number
    2531779-2011-03852
    Event Type
    Injury
    Date Received
    June 1, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 12/15/2011-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE 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. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT THE PATIENT HAD THREE HYPOGLYCEMIC EPISODES WHILE HIS DIABETES WAS MANAGED WITH THE ANIMAS PUMP. ON (B)(6) AT 6AM, THE PATIENT TOOK FOOD/DRINK FOR A BLOOD GLUCOSE READING OF 54 MG/DL. HIS BLOOD GLUCOSE EVENTUALLY RETURNED TO THE NORMAL RANG IN THE LOW 100 MG/DL. THE FOLLOWING DAY AT 4 AM, THE PATIENT HAD SYMPTOM OF SWEATY AND TESTED AT 31 MG/DL. THE PATIENT TOOK TREATMENT WITH GLUCOSE TABLETS, (B)(6), AND A SANDWICH. HIS BLOOD GLUCOSE ELEVATED TO 111 MG/DL AND REMAINED STABLE THROUGHOUT THE DAY. ON (B)(6) AT 4 AM, THE PATIENT'S BLOOD GLUCOSE WAS AT 50 MG/DL. HE ONCE AGAIN ATE A SANDWICH TO ELEVATE HIS BLOOD GLUCOSE AT THE TIME OF CONCERN. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE CONFIRMED THE ANIMAS PUMP WAS WORKING ACCORDINGLY. THE PATIENT'S WIFE DECREASED THE BASAL RATE AT THE TIME OF CONCERN AND INDICATED THAT THE INSULIN DOSE WAS BE ADJUSTED AFTER SHE CONSULT WITH HIS HEALTHCARE PROVIDER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY HAD 3 HYPOGLYCEMIC EPISODES WHILE HE MANAGED HIS DIABETES WITH THE ANIMAS 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 50 YR Life Threatening| R