BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2103242 · Received May 25, 2011

    Report

    Report Number
    2531779-2011-03714
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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

    FOLLOW-UP # 1 DATE OF SUBMISSION 07/05/2011-DEVICE EVALUATION: THE PUMP AND METER HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP POWERS UP TO THE VERIFY SCREEN WITH FUNCTIONAL AUDITORY AND VIBRATORY ALARMS. THE PUMP WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. A REVIEW OF THE TOTAL DAILY DOSE HISTORY FROM (B)(6) 2010 TO THE END OF PUMP USE ON (B)(6) 2011 INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THERE WERE NO ALARMS OR CONDITIONS NOTED IN THE PUMP HISTORY THAT WOULD INDICATED A PUMP MALFUNCTION. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO INSULIN DELIVERY ISSUES. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DISCOLORED DISPLAY SCREEN AND AN INTERMITTENTLY RESPONSIVE CONTRAST BUTTON, WHICH HAVE NO EFFECT ON INSULIN DELIVERY FUNCTION. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THE PUMP WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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 REPORTER CLAIMED THAT HER BLOOD GLUCOSE WAS ELEVATED TO 400 MG/DL WITH SYMPTOMS OF HYPERGLYCEMIA WHILE SHE MANAGED HER DIABETES WITH THE ANIMAS PUMP. HER BLOOD GLUCOSE WAS OUT OF HER USUAL TARGET RANGE OF 100-150 MG/DL. HER BLOOD GLUCOSE REPORTEDLY HAS BEEN TRENDING HIGH. ON THE DAY OF THE CALL TO ANIMAS HER BLOOD GLUCOSE WENT AS LOW AS "58 MG/DL" AFTER SHE SIGNIFICANTLY INCREASED HER BASAL RATE AND EXERCISE BASED ON THE ALLEGED ELEVATED READING. DURING TROUBLESHOOTING, THE PATIENT NOTED THE FOLLOWING: HER BLOOD GLUCOSE WAS WITHIN THE TARGET RANGE WHEN SHE DISCONTINUED USING THE SUBJECT ANIMAS PUMP AND BEGAN TO USING THE OLD PUMP. THERE WAS NO AIR IN THE SYSTEM OR SITE ISSUES. THE CANNULA WAS BENT DURING (B)(6) 2011. THE DATE AND TIME WAS CORRECT AS WELL AS ALL THE INSULIN SETTINGS. THERE WAS NO EVIDENCE OF A PRODUCT MALFUNCTION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA WHILE SHE MANAGED HER 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 59 YR Life Threatening| R