BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3173018 · Received June 17, 2013

    Report

    Report Number
    2531779-2013-08321
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/22/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT THE LAST BASAL AND LAST BOLUS DELIVERY WAS RECORDED ON (B)(6) 2013. THE TOTAL DAILY DOSE ADDED UP CORRECTLY AND REFLECTED THE USERS PROGRAMMED BASAL RATES. TYPICAL USAGE WAS NOTED IN PUMP ALARM HISTORY. THE PUMP WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATION DURING THE 29 HOUR FLOW ACCURACY TEST. 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 CONFIRM HER INSULIN PUMP IS WORKING PROPERLY. REPORTEDLY, HER BLOOD GLUCOSE READINGS HAVE BEEN IN THE 500¿S MG/DL FOR THE PAST 5 DAYS DUE TO POSSIBLE OTHER HEALTH CONDITIONS UNRELATED TO DIABETES. THE PATIENT HAS HAD 2 PANCREAS TRANSPLANTS. HER LIVER RELEASES GLUCOSE RANDOMLY FOR NO KNOWN REASON AND THE PATIENT HAS TO TAKE BOLUS INSULIN. IN ADDITION, SHE HAD THYROID ISSUES. IN THE PAST 3 WEEKS, THE PATIENT HAS HAD EXCESSIVE WEIGHT GAIN. SHE IS EXPECTED TO MEET WITH HER ENDOCRINOLOGIST TO INCREASE HER THYROID MEDICATION AND TO REVIEW HER INSULIN REGIMEN. ON (B)(6) 2013, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS TAKEN OF OFF INSULIN PUMP THERAPY. SHE HAD SYMPTOMS DESCRIBED AS ¿NAUSEA, VOMITING, ABDOMINAL PAIN, AND MILD SHORTNESS OF BREATH AT THE TIME OF ADMISSION. SHE WAS TREATED WITH IV INSULIN, INSULIN VIA SYRINGES, AND IV FLUID. SINCE BEING ADMITTED, THE PATIENT'S DOCTOR TRIED TO RESUME INSULIN PUMP THERAPY BUT THE PATIENT¿S BLOOD GLUCOSE DID NOT RESPOND. IN ADDITION, THE PATIENT INDICATED THAT HER HCP IS HAVING A HARD TIME REGULATING HER BLOOD GLUCOSE WHILE SHE IS OFF OF INSULIN PUMP THERAPY. DURING THE CALL TO ANIMAS, THE PATIENT WAS STILL BEING TREATED AT THE HOSPITAL. 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 SUBJECT PUMP DELIVERED INSULIN ACCORDINGLY WITHOUT ANY ISSUE. THE ANIMAS REPRESENTATIVE CONCLUDED THERE WAS NO PUMP MALFUNCTION ASSOCIATED WITH THE ALLEGED EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REQUIRED HCP MEDICAL INTERVENTION WHILE SHE WAS ON INSULIN PUMP THERAPY. ALTHOUGH HER HIGH BLOOD GLUCOSE COULD POSSIBLY BE DUE TO OTHER HEALTH ISSUES, THE ANIMAS INSULIN PUMP COULD NOT BE RULED OUT AS A CONTRIBUTOR OF THE REPORTED EVENT. HENCE, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273782 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| L| R