BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2760516 · Received September 26, 2012

    Report

    Report Number
    2531779-2012-11256
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    August 28, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2012-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWS EVIDENCE OF REBOOTING. VISUAL INSPECTION REVEALED A BATTERY COMPARTMENT CRACK AND STRIPPED THREADS ON THE BATTERY CAP. THE BATTERY CAP WAS UNABLE TO MAINTAIN AN ELECTRICAL CONNECTION TO THE PUMP. A TEST BATTERY CAP WAS ABLE TO SECURE PROPERLY TO THE PUMP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO FURTHER POWER ISSUES OCCURRING. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DISCOLORED/FADED 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

    ON (B)(6) 2012, THE LAY-USER/PATIENT CONTACTED ANIMAS (ANM) ALLEGING A POWER ISSUE WITH THE PUMP. THE PATIENT CLAIMED THAT THE PUMP WAS POWERING OFF. THE PATIENT INDICATED THAT SHE HAD PUT A BATTERY IN THE PUMP ON THE PREVIOUS SUNDAY. ON (B)(6) 2012, THE PATIENT NOTICED THAT THE PUMP WAS POWERING OFF AND SHE COULD NOT SECURE THE BATTERY CAP TO THE PUMP. THAT SAME DAY, THE PATIENT REPORTEDLY NOTICED A CRACK ON THE PUMP'S BATTERY COMPARTMENT. HOWEVER, THE PATIENT DID NOT KNOW WHEN THE CRACK OCCURRED. DURING THE TIME OF CONCERN, THE PATIENT MENTIONED THAT HER BLOOD GLUCOSE (BG) LEVELS REACHED "300-385 MG/DL." SHE ALSO REPORTED HAVING TRACE KETONES BUT DENIED HAVING ANY SYMPTOMS OF HYPERGLYCEMIA. THE PATIENT HAD STARTED SUBCUTANEOUS INJECTIONS THAT SAME DAY AT 3:00 PM. THE PATIENT MENTIONED THAT SHE WAS RECOVERING FROM POST-OP SURGERY RELATED TO HAVING PINS IN HER HAND. THE PATIENT WAS AWARE THAT SURGERY CAN AFFECT BG LEVELS. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE PUMP WAS REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT THE PUMP HAD A POWER ISSUE THAT WAS NOT RESOLVED WITH TROUBLESHOOTING. HOWEVER, THERE IS NO EVIDENCE THAT THE PUMP CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY BLOOD GLUCOSE READINGS, SYMPTOMS, AND/OR TREATMENT SUGGESTIVE OF A SERIOUS INJURY.

    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