BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2680425 · Received August 3, 2012

    Report

    Report Number
    2531779-2012-07618
    Event Type
    Malfunction
    Date Received
    August 3, 2012
    Report Date
    July 11, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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

    (B)(4): A RETAINED CARTRIDGE SAMPLE FROM LOT # B201747 WAS EVALUATED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FILL TEST, AND FORCE TEST WAS PERFORMED WITH NO FAILURES OBSERVED. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #2 SUBMITTED: (B)(4) 2012. DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY REVEALED LOSS OF PRIME WITH ZERO FORCE. A REWIND, LOAD AND PRIME SEQUENCE WAS PERFORMED WITH NO LOSS OF PRIME. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL PROGRAM WITH NO LOSS OF PRIME DUPLICATED. A FORCE SENSOR CALIBRATION TEST REVEALED THE FORCE SENSOR TO BE WITHIN SPECIFICATIONS. THE DISPLAY LENS COVER WAS REMOVED FOR INVESTIGATION AND REVEALED FLEX PINS PARTIALLY DISLODGED FROM THE PRINTED CIRCUIT BOARD SOCKET.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 ALLEGING THAT THE PUMP HAS BEEN EMITTING FREQUENT LOSS OF PRIME WARNINGS OVER THE LAST EIGHT MONTHS. THE PATIENT REPORTED THAT ON THREE-TO-FIVE OCCASIONS, THE PUMP HAS PUSHED ALL OF THE INSULIN OUT WHILE HE WAS ATTEMPTING TO LOAD THE CARTRIDGE. THE PATIENT STATED THAT HE HAS TRIED NEW CARTRIDGES WITHOUT RESOLUTION OF THE PROBLEM. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGED LOAD STEP MALFUNCTION.

    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 37 YR