BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2912444 · Received January 12, 2013

    Report

    Report Number
    2531779-2013-00577
    Event Type
    Malfunction
    Date Received
    January 12, 2013
    Report Date
    December 15, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN 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 #1 DATE OF SUBMISSION 04/15/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE DAILY INSULIN DELIVERY TOTALS WERE REVIEWED AND CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES SHOWING THE PUMP WAS DELIVERING ACCURATELY UP UNTIL THE LAST DATE USED BY THE PATIENT. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT DURING INVESTIGATION. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY LENS WAS FOUND TO BE SCRATCHED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS TO REPORT THAT HER BLOOD GLUCOSE HAS BEEN HIGH IN THE 400 MG/DL AND HAD DIFFICULTIES KEEPING HER BLOOD GLUCOSE UNDER CONTROL WHILE ON INSULIN PUMP THERAPY. THE PATIENT REPORTEDLY DID NOT HAVE ANY SYMPTOMS OF HYPERGLYCEMIA. THE PATIENT REPORTEDLY TOOK BOLUS INSULIN WITH THE SUBJECT INSULIN PUMP AFTER SHE CHANGED HER SITE/INFUSION BUT HER BLOOD GLUCOSE DID NOT RESPOND. SUBSEQUENTLY, HER BLOOD GLUCOSE WAS LOWERED TO 75 MG/DL WITH TWO DOSES OF INSULIN VIA SYRINGE. HER BLOOD GLUCOSE ROSE AGAIN AFTER SHE ATE AND TOOK BOLUS INSULIN VIA THE SUBJECT PUMP. THE PATIENT DOES NOT FEEL COMFORTABLE WITH THE SUBJECT INSULIN PUMP. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE ASSESSED THE PATIENTS ALLEGED BLOOD GLUCOSE EXCURSION BY EVALUATING THE ANIMAS PUMP. THE ADVANCE FEATURES AND THE BASAL SEGMENT ARE CORRECTLY PROGRAMMED ACCORDING TO THE PATIENT'S USAGE. THE DATE AND TIME WAS CONFIRMED TO BE ACCURATE. THERE WAS NO PRODUCT MISUSE. THE SUBJECT PUMP WAS REQUESTED BACK FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED DUE TO AN ALLEGED INACCURATE DELIVERY ISSUE. THE PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION THAT WOULD SUGGEST A SERIOUS INJURY AT THE TIME OF CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19412 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR