BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2833965 · Received November 15, 2012

    Report

    Report Number
    2531779-2012-13653
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    October 18, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 8/5/16 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/15/2016 WITH THE FOLLOWING FINDINGS:.#1. THE BLACK BOX BEGINS ON (B)(6) 2016. DUE TO CONTINUOUS USE OF THE PUMP THE BLACK BOX DATA/HISTORIES FOR THE EVENT HAVE BEEN OVERWRITTEN. AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES..#2. PUMP PASSED DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT'S MOTHER/REPORTER CONTACTED ANIMAS TO REPORT THE PATIENT HAD SOME BLOOD GLUCOSE EXCURSIONS WHILE THE PATIENT'S DOCTOR MADE SOME ADJUSTMENT TO THE PATIENT'S INSULIN REGIMENT. DURING THE PRIOR WEEK BEFORE THE CALL TO ANIMAS, THE PATIENT REPORTEDLY HAD SOME LOW BLOOD GLUCOSE READINGS WHICH WERE RESOLVED WITH A CORRECTION IN THE PATIENT'S BASAL RATE. FOR THE PAST FEW DAYS, THE PATIENT HAD BEEN RUNNING HIGH BLOOD GLUCOSE IN THE 300'S MG/DL AND 400'S MG/DL. ON (B)(6) 2012, THE PATIENT'S BLOOD GLUCOSE FLUCTUATED BETWEEN 217 MG/DL TO 476 MG/DL. ON THAT DAY, WHEN THE PATIENT'S BLOOD GLUCOSE WAS OVER 400 MG/DL, HE REPORTEDLY TESTED POSITIVE FOR LARGE KETONES. AFTER THE PATIENT DRANK WATER, CONTINUED ON INSULIN PUMP THERAPY, AND INCREASED HIS ACTIVITY BY MOWING THE LAWN, HIS KETONES HAS BEEN NEGATIVE. THE REPORTER INDICATED THAT HIS BLOOD GLUCOSE READING USUALLY DECREASES WITH EXERCISE. THE REPORTER ALSO NOTED THE PATIENT WAS ON FALL BREAK AND HAS BEEN LESS ACTIVE THAN USUAL WHICH CAN ACCOUNT FOR THE RECENT ELEVATED BLOOD GLUCOSE READINGS. THE PATIENT'S DOCTOR TOOK THE PATIENT OFF OF INSULIN PUMP THERAPY AND TREATED THE PATIENT WITH LEVIMIR INSULIN AS WELL AS WITH SOME BOLUS INSULIN DOSE ON (B)(6) 2012 WHEN HIS AM BLOOD GLUCOSE READING WAS AT 333 MG/DL. THE PATIENT'S SITE WAS CHANGED AND HIS TEMPORARY BASAL RATE WAS TURNED OFF DURING THE DOCTOR'S VISIT. ON THAT SAME DAY, THE PATIENT EVENTUALLY CONTINUED ON INSULIN PUMP THERAPY. THE PATIENT WAS GIVEN BOLUS DOSAGES VIA THE PUMP AND SYRINGE. DURING THE TIME OF THE PATIENT'S SITE CHANGE, HIS BLOOD GLUCOSE READ 355 MG/DL. BY DINNER TIME, HIS BLOOD GLUCOSE DECREASED TO 265 MG/DL AND EVENTUALLY TO 261 MG/DL AT 8:29 PM. THE ANIMAS REPRESENTATIVE CONCLUDED THERE WAS NO PUMP MALFUNCTION ASSOCIATED WITH THE ALLEGED EVENT. THE ADVANCE FEATURES AND THE BASAL SEGMENT ARE CORRECTLY PROGRAMMED ACCORDING TO THE PATIENT'S USAGE AT THE TIME OF THE EVENT. THE DATE AND TIME WAS CONFIRMED TO BE ACCURATE. THE PUMP DELIVERED INSULIN ACCORDINGLY AND NO INACCURATE DELIVERY ISSUE WAS FOUND. THERE WAS NO PRODUCT MISUSED. THE REPORTER WAS ENCOURAGED TO SPEAK WITH THE PATIENT'S DOCTOR ABOUT THE PATIENT'S RECENT BLOOD GLUCOSE EXCURSION, SITE CHANGES, INSULIN REGIMEN SETTINGS, RECENT FEVER, COUGH MEDICATION, AND HORMONAL CHANGES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD UNEXPLAINED HIGH BLOOD GLUCOSE OVER 400 MG/DL AND TESTED POSITIVE FOR LARGE KETONES WHILE ON INSULIN PUMP THERAPY. ALTHOUGH THERE WAS NO EVIDENCE OF PRODUCT MALFUNCTION, THE ANIMAS INSULIN PUMP CANNOT BE RULED OUT AS A CONTRIBUTOR.

    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 12 YR Life Threatening| R