BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2775577 · Received October 8, 2012

    Report

    Report Number
    2531779-2012-11953
    Event Type
    Malfunction
    Date Received
    October 8, 2012
    Report Date
    September 13, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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: 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. REVIEW OF THE BLACK BOX REVEALED LOSS OF PRIME WITH ZERO FORCE. A REWIND, LOAD AND PRIME SEQUENCE WAS PERFORMED WITHOUT LOSS OF PRIME. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL PROGRAM WITH NO LOSS OF PRIME. THE FORCE SENSOR WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATIONS. INVESTIGATION OF THE INSIDE OF THE PUMP REVEALED FORCE SENSOR FLEX PINS WERE FOUND TO BE PARTIALLY DISLODGED FROM THE PRINTED CIRCUIT BOARD. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DISCOLORED DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 ALLEGING THE PUMP WAS HAVING AN ISSUE INVOLVING FREQUENT LOSS OF PRIME OCCURRING OVER THE PAST EIGHT MONTHS. DURING TROUBLESHOOTING, THERE WERE OCCLUSION ALARMS RECORDED IN THE ALARM HISTORY. THE REPORTER STATED THERE WAS ALSO LOSS OF PRIME WARNINGS OCCURRING INDEPENDENTLY OF THE OCCLUSION ALARMS. THE PATIENT REPORTED HAVING CHANGED THE CARTRIDGES MULTIPLE TIMES AND USE OF NEW, DIFFERENT CARTRIDGES WITHOUT RESOLUTION. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    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 38 YR