BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2151825 · Received July 6, 2011

    Report

    Report Number
    2531779-2011-04722
    Event Type
    Injury
    Date Received
    July 6, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP POWERS UP PROPERLY WITH AUDIBLE TONES. INVESTIGATION CONFIRMED THAT THE BATTERY COMPARTMENT IS CRACKED. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DISCOLORED DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE (B)(4) INSTRUCTS THE USER TO CALL ANIMAS (B)(4) IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED.

    Additional Manufacturer Narrative · 1

    (B)(6). IT WAS REPORTED THAT THE BATTERY COMPARTMENT WAS DAMAGED. THE ALLEGED MALFUNCTION IS NOT LIKELY TO CAUSE AN ADVERSE EVENT. THE ISSUE IS GENERALLY OBVIOUS AND DETECTABLE BY THE USER. THEREFORE THE DETECTABLE FLAW MAY PREVENT THE USER FROM CONTINUING USE OF THE DEVICE OR CAUSE A CONDITION THAT MAKES CONTINUED USE OF THE DEVICE IMPOSSIBLE. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED. THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 DATE OF SUBMISSION (B)(4) 2011-DEVICE EVALUATION: ADDITIONAL EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY FROM (B)(4) 2011 TO THE END OF PUMP USE ON (B)(4) 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. THERE WERE NO INSULIN DELIVERY DEFECTS FOUND ON INVESTIGATION. 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

    A FAMILY MEMBER REPORTED THAT THE PATIENT EXPERIENCED BLOOD GLUCOSE (BG) BETWEEN 300 AND 400 MG/DL WITH MODERATE KETONES LAST WEEK. SHE STATED THAT THE PATIENT'S BG RESOLVED TO 112 MG/DL AFTER BOLUSING. SHE STATED THAT THE PATIENT PERFORMED A SITE/SET CHANGE (B)(6), AND DISCOVERED THAT THE CANNULA WAS BENT. THE FAMILY MEMBER WAS UNSURE OF THE DATE(S) OF OCCURRENCE FOR THE BG EXCURSION AND THE SITE CHANGE/BENT CANNULA. THE FAMILY MEMBER REPORTED THAT THE PUMP HAS BEEN REBOOTING TWO TO THREE TIMES A DAY FOR (B)(6). SHE STATED THAT THE BATTERY COMPARTMENT WAS CRACKED, AND THE BATTERY CAP WOULD SOMETIMES BECOME LOOSE. SHE NOTED THAT THE BATTERY CAP WAS CHANGED (B)(6) AGO. THE USER GUIDE RECOMMENDS THAT THE USER CHANGE THE BATTERY CAP EVERY SIX MONTHS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PUMP CANNOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT.

    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 13 YR Required Intervention