BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6216408 · Received December 30, 2016

    Report

    Report Number
    2531779-2016-35107
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Report Date
    December 10, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 01/27/2017: 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. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/11/2017 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX SHOWED AN OCCLUSION ALARM ON (B)(6) 2016 11:37; THE FORCE AT THE TIME OF OCCLUSIONS IS HIGH. THE PUMP WAS THEN MANUALLY SUSPENDED ON (B)(6) 2016 16:38 AND MANUALLY RESUMED AT 18:17. INSULIN DELIVERIES RESUMED AT (B)(6) 2016 18:20. THE BLACK BOX SHOWED AN OCCLUSION ALARM ON (B)(6) 2016 05:51; THE FORCE AT TIME OF OCCLUSIONS IS HIGH. INSULIN DELIVERIES RESUMED AT 07:28. TWO ADDITIONAL OCCLUSION ALARMS WITH HIGH FORCE WERE OBSERVED ON (B)(6) 2016 AT 16:41 AND 16:53. DURING INVESTIGATION, REWIND, LOAD CARTRIDGE, AND PRIME STEPS WERE PERFORMED SUCCESSFULLY WITH NO ALARMS. THE PUMP WAS DETERMINED TO BE DETECTING CORRECT FORCE DURING INVESTIGATION. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO OCCLUSIONS OCCURRING. THE TOTAL DAILY DOSES ADDED UP CORRECTLY TO REFLECT THE USER¿S PROGRAMMED BASAL RATES. THE PUMP PASSED DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN RANGE. THE PUMP WAS OPENED FOR INVESTIGATION; NO EVIDENCE OF INTERNAL MOISTURE OR DAMAGE TO THE PRINTED CIRCUIT BOARD OR INTERNAL COMPONENTS WAS OBSERVED. INVESTIGATION DID NOT DUPLICATE THE COMPLAINT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 CARTRIDGE WAS RETURNED TO ANIMAS AND INVESTIGATION COMPLETED ON 02/02/2017 WITH THE FOLLOWING RESULTS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST/FORCE TEST/FILL TEST WAS PERFORMED WITH NO FAILURES OBSERVED OR FLUID OBSERVED LEAKING OUT AT THE PLUNGER END OF THE CARTRIDGE. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2016 ALLEGING THE PATIENT WAS HOSPITALIZED WHILE ON INSULIN PUMP THERAPY WITH BLOOD GLUCOSE MEASURING 878 MG/DL AND SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA OF LETHARGY, INCOHERENCY AND VOMITING. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND DIAGNOSED WITH DIABETIC KETOACIDOSIS. THE PATIENT WAS DISCONTINUED FROM INSULIN PUMP THERAPY AND TREATED WITH INSERTION SITE CHANGE, INTRAVENOUS FLUIDS AND INSULIN DRIP. THE REPORTER ALLEGED THAT THE PATIENT¿S SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY WAS ATTRIBUTED TO OCCLUSION ALARMS. THE PATIENT¿S HEALTH CARE PROVIDED INSISTED THAT THE PUMP BE REPLACED TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY ALLEGEDLY ASSOCIATED WITH A PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866059 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R