BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2820366 · Received November 6, 2012

    Report

    Report Number
    2531779-2012-13205
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: (B)(4) 2012 - A RETAINED CARTRIDGE SAMPLE FROM LOT #B201457 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE DATA FROM THE TIME OF THE REPORTED EVENT IS UNAVAILABLE FOR REVIEW DUE TO CONTINUED PUMP USE. DURING INVESTIGATION, THE PUMP DID NOT RECOGNIZE THE CARTRIDGE AND DISPENSED FLUID DURING THE LOAD STEP. THE PUMP EMITTED A "NO CARTRIDGE DETECTED" WARNING. INVESTIGATION REVEALED THAT THE FORCE SENSOR WAS OUT OF CALIBRATION AND THE FORCE RESISTANCE MEASUREMENT WAS OUT OF SPECIFICATION. INVESTIGATION ALSO REVEALED THAT THE FORCE SENSOR WAS DAMAGED AND THERE WAS EVIDENCE OF CONTAMINATION ON THE FORCE SENSOR. UNRELATED TO THE IDENTIFIED FORCE SENSOR ISSUE, EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT AND FADED DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/OR THE WATERPROOF FEATURE OF THE PUMP. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED. (B)(6). CORRECTION NUMBER: 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE FORCE SENSOR WAS OUT OF CALIBRATION AND THE FORCE RESISTANCE MEASUREMENT WAS OUT OF SPECIFICATION. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2012.

    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 56 YR