BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2990280 · Received March 5, 2013

    Report

    Report Number
    2531779-2013-02382
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    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 # 1 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY REVEALED MULTIPLE MANUAL TIME AND DATE CHANGES AROUND THE TIME OF THE EVENT. A TIMEKEEPING ACCURACY TEST WAS PERFORMED AND THE PUMP MAINTAINED THE TIME AND DATE ACCURATELY. THE COMPLAINT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    ON (B)(4) 2013, THE REPORTER CONTACTED ANIMAS AND STATED HIS DAUGHTER HAD BEEN HAVING ERRATIC BLOOD GLUCOSE (BG) LEVELS FOR 1-2 WEEKS. AT TIME OF CALL BG IS IN 400 MG/DL RANGE. DAD HAS CONTACTED THE HEALTH CARE PROVIDER (HCP) AND EDUCATOR REGARDING THE SITES. DAD JUST WANTS TO TROUBLESHOOT THE PUMP TO BE SURE THE PUMP IS DELIVERING AS INTENDED. DAUGHTER'S BGS VARIED AS FOLLOWS: (B)(6) 2013 AT 1:30 / 457, 10:30 AM / 372, 8:26 AM / 255, 6:27 AM / 268, 2:30 AM / 479; (B)(6) 2013 9:14 PM / 112, 7:30 PM / 145, 4:45 PM / 386, 1:01 PM / 267, 10 AM / 267 AND 7:05 AM / 169. DAD ADAMANT DAUGHTER IS CHANGING SITE AS INSTRUCTED. SHE IS ROTATING SITES ON ABDOMEN, BUT DAD FEELS SHE MAY BE STAYING IN THE SAME SMALL AREA. DAD IN A HURRY, AGAIN STATES JUST WANTS TO GO THROUGH THE PUMP. HAD DAD REMOVE THE BATTERY AND RESET PUMP, TIME/DATE MAINTAINED CORRECT. CONFIRMED ALL SETTINGS CORRECT IN PUMP, PRIME HISTORY CORRECT, PRIME CORRECT, BUT TIME DATE WAS OFF ON (B)(6). TDD HISTORY INDICATES 2 DATES OF(B)(6), WHICH THE PATIENT IS UNABLE TO EXPLAIN. THEN ON (B)(6) AM/PM TIME WAS TRANSPOSED, READ 4:50P -0-, 5P/1.1, 11A/1.O, AND THEN BACK TO 5P/1.1, BOLUS SKIPPED FROM (B)(6) AND BACK TO (B)(6) AGAIN. BOLUS CORRECT. ALL OTHER SETTINGS WERE CORRECT. THE PATIENT IS ADAMANT SHE DID NOT TOUCH THE TIME /DATE. THE BLOOD GLUCOSE EXCURSIONS DO NOT MEET THE CRITERIA FOR AN ADVERSE EVENT, AND THIS COMPLAINT IS BEING REPORTED DUE TO THE UNEXPLAINED DISCREPANCY IN DATE AND TIME ON (B)(6), WHICH MAY HAVE ALTERED INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93079 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR