BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3172913 · Received June 17, 2013

    Report

    Report Number
    2531779-2013-08307
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 (B)(4): THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: THE COMPLAINT COULD NOT BE DUPLICATED DURING THE INVESTIGATION. NO DEFECT WAS FOUND. PUMP WAS SUBJECT TO A 29HR FLOW ACCURACY TEST; THE PUMP WAS FOUND TO BE DELIVERING WITHIN THE SPECIFIED RANGE. THE DELIVERED BOLUSES AND BASALS ADD UP CORRECTLY TO EQUAL THE TOTAL THE DAILY INSULIN DELIVERY RATE WHICH WAS PROGRAMMED BY THE USER. THERE ARE NO ERRORS OR ALARMS ASSOCIATED WITH THE COMPLAINT IN THE BLACK BOX OR ALARM HISTORY. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY-USER/PATIENT CONTACTED ANIMAS TO REPORT THAT HER DIABETES HAS BECOME UNMANAGEABLE SINCE SHE HAS BEEN ON THE ANIMAS INSULIN PUMP FOR THE LAST TWO MONTHS. HER BLOOD GLUCOSE TARGET RANGE OF 120-128 MG/DL REPORTEDLY HAS NOT BEEN MET. ON (B)(6) 2013, THE PATIENT WAS ADMITTED TO THE ICU FOR DKA. THE PATIENT STATES THAT HER BLOOD GLUCOSE READINGS HAVE BEEN OUT OF RANGE FOR SEVERAL MONTHS BUT HAVE NEVER REACH MORE THAN 600 MG/DL UNTIL THE DAY PRIOR TO AND DURING HER HOSPITAL ADMISSION. REPORTEDLY, HER BLOOD GLUCOSE BECAME ELEVATED ON (B)(6) 2013, TO 500-600 MG/DL. AT THE TIME OF CONCERN, THE PATIENT MADE SEVERAL HOURLY INSULIN BOLUS CORRECTIONS PER THE DOCTOR'S RECOMMENDATION BUT HER HIGH BLOOD GLUCOSE READING DID NOT ABATE. THE PATIENT HAD SYMPTOMS OF SEVERE VOMITING AND WAS DEHYDRATED. THE PATIENT SUBSEQUENTLY WAS TAKEN TO THE ER WHERE SHE RECEIVED INSULIN INJECTION VIA SYRINGE AND WAS PLACED ON AN IV DRIP. ABOUT 24 HOURS AFTER HER ADMISSION, HER IV INSULIN TREATMENT WAS DISCONTINUED AND THE PATIENT RECEIVED AN ALTERNATE FORM OF INSULIN DELIVERY. THE PATIENT'S BLOOD GLUCOSE RETURNED TO BASELINE OF 120 MG/DL WHERE IT REMAINED AT THIS TIME. THE PATIENT WAS DISCHARGED ON (B)(6) 2013 AND WAS ADVISED BY HER DOCTOR TO DISCONTINUE INSULIN PUMP THERAPY UNTIL SHE RECEIVES HER REPLACEMENT PUMP. THE PATIENT STATED HER A1C LEVEL HAS CLIMBED FROM 4.6 TO OVER 12 IN THE LAST 2 MONTHS EVEN WITH BASAL RATE CHANGES ON THE SUBJECT PUMP. HER HCP DOES NOT FEEL THE PUMP IS WORKING AND WANTS IT REPLACED. THE PATIENT CLAIMED THAT WHEN THE INFUSION SET WAS REMOVED FROM THE SITE, THE CANNULA WAS NOT KINKED OR BENT. THERE WAS NO SCAR TISSUE OR LUMPY OR HARD AREAS. THE PATIENT IS CURRENTLY OFF OF INSULIN PUMP THERAPY AND IS ON INSULIN INJECTION VIA SYRINGE. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE ASSESSED THE PATIENT'S 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. THE ANIMAS PRODUCT WAS REQUESTED BACK FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD UNCONTROLLABLE ELEVATED BLOOD GLUCOSE AND REQUIRED MEDICAL INTERVENTION FOR HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274374 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| L| R