BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2172739 · Received July 22, 2011

    Report

    Report Number
    2531779-2011-05124
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES. 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 WAS HOSPITALIZED ON (B)(6) 2011 WITH BLOOD GLUCOSE RESULTS AROUND 500-600 MG/DL. THE PATIENT REPORTEDLY HAD SYMPTOMS OF VOMITING AT THE TIME OF CONCERN. WHILE THE PATIENT MANAGED HIS DIABETES WITH THE ANIMAS PUMP DURING THE MONTH OF (B)(6) 2011, HIS BLOOD GLUCOSE HAS REMAINED AROUND 300-400 MG/DL WITH SYMPTOMS OF NAUSEA AND VOMITING OFF AND ON. ON (B)(6) 2011, THE PATIENT REPORTEDLY HAD A LOW BLOOD GLUCOSE READING OF "58 MG/DL" AFTER HE TOOK LANTUS INSULIN ON HIS OWN ACCORD WHILE HE WAS ON THE ANIMAS PUMP. IT WAS NOTED THAT THE PATIENT'S DOCTOR DID NOT RECOMMEND HE TAKE LANTUS INSULIN IF HE WAS TAKING INSULIN TREATMENT VIA THE PUMP. HIS BLOOD GLUCOSE WAS CORRECTED WITH FOOD. DURING TROUBLESHOOTING, THE PATIENT NOTED THAT THE PUMP SETTING IS PROGRAMMED ACCORDINGLY WITH THE CORRECT BASAL SEGMENT, TIME AND DATE, HISTORY, AND ADVANCE FEATURES. THERE IS NO PRODUCT MISUSE. THE PATIENT IS USING HUMALOG INSULIN TO MANAGE HER DIABETES. THE HUMALOG IS IN GOOD CONDITION AND WITHIN THE EXPIRATION DATE. THERE WERE NO AIR BUBBLES OR LEAKS IN THE TUBING OR CARTRIDGE. THE CANNULA WAS NOT BENT. NO ISSUES WERE FOUND WITH INSULIN SITE. THE PATIENT WENT ON THE BACKUP PLAN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT MANAGED HIS DIABETES WITH THE ANIMAS PUMP AND SUBSEQUENTLY HAD SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AND RECEIVED MEDICAL INTERVENTION FOR ELEVATED BLOOD GLUCOSE.

    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 44 YR