BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2232069 · Received September 1, 2011

    Report

    Report Number
    2531779-2011-06425
    Event Type
    Injury
    Date Received
    September 1, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. A REVIEW OF THE SUSPEND HISTORY SHOWS THAT PUMP WAS SUSPENDED ON (B)(6) 2011 AT 10:29PM AND IMMEDIATELY RESUMED. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO INSULIN DELIVERY ISSUES OCCURRING. THERE WERE NO DEFECTS FOUND ON INVESTIGATION.

    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 CONCLUSIONS CAN BE MADE AT THIS TIME. 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

    THE PATIENT CLAIMED HE EXPERIENCED A LOW BLOOD GLUCOSE READING OF 26 MG/DL ON (B)(6) 2011. THE PATIENT AWOKE THAT DAY AND TESTED AT 104 MG/DL. HE WENT BACK TO SLEEP WITH WIFE. HER WIFE WOKE UP WHEN SHE HEARD THE PATIENT BREATHING ERRATICALLY AND TESTED THE PATIENT AT 26 MG/DL. THE PARAMEDICS WERE CONTACTED. UPON ARRIVAL, THE PATIENT WAS TREATED WITH GLUCAGON AT 1 PM AND WAS TAKEN TO THE HOSPITAL. THE PATIENT WAS GIVEN FOOD AT THE HOSPITAL AND WAS DISCHARGED AT 6 PM WITH A BLOOD GLUCOSE READING OF 160 MG/DL. THE PATIENT RESUMED PUMP TREATMENT AFTER HIS RELEASE. THE ANIMAS REPRESENTATIVE WENT THROUGH TROUBLESHOOTING WITH THE ANIMAS PUMP TO ASSESS THE PATIENT'S ALLEGED LOW BLOOD GLUCOSE AT THE TIME OF CONCERN. THE TOTAL DAILY DOSE OF INSULIN WAS ALL ACCOUNTED FOR. THE PATIENT CONFIRMED ALL HIS BOLUS INSULIN WAS AS INTENDED. THE ANIMAS PUMP WAS SUSPENDED AND RESUMED ON MANY OCCASION ON THE DAY OF CONCERN. REPORTEDLY, THE ANIMAS PUMP WAS EXPOSED TO MRI APPROXIMATELY 3 WEEKS AGO. THE ANIMAS REPRESENTATIVE CONCLUDED THERE WAS NO PUMP MALFUNCTION ASSOCIATED WITH THE ALLEGED EVENT. IT IS NOT CLEAR WHAT CONTRIBUTED TO THE PATIENT'S LOW BLOOD GLUCOSE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FOR HYPOGLYCEMIA 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 68 YR Hospitalization| L| R