BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1792035 · Received August 10, 2010

    Report

    Report Number
    2939301-2010-06406
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Report Date
    July 22, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE THERE WERE MALFORMED CLIPS. ANOTHER CLIP APPLIER WAS USED TO COMPLETE THE CASE. THERE WAS NO PT CONSEQUENCE.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6), 2010 ALLEGING THAT HE DEVELOPED "HIGH BG" AS A RESULT OF BUTTON, DISPLAY (CONTRAST), AND INACCURACY ISSUES WITH HIS ONETOUCH PING METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE PATIENT CLAIMED THAT THE BUTTON, DISPLAY, AND INACCURACY ISSUES FIRST OCCURRED "ABOUT 6 MONTHS AGO." THE PATIENT STATED THAT THE "OK," "BACK," "UP," AND "DOWN" BUTTONS HAD DELAYED RESPONSES, THE "DOWN" AND "UP" BUTTONS WAS ALSO HARD TO PRESS, AND THAT THERE WAS A CONTRAST ISSUE WITH THE METER'S DISPLAY. IT IS UNKNOWN IF THESE REPORTED ISSUES IMPACTED THE PATIENT'S TESTING WITH THE METER. HE ALSO REPORTED THAT HIS METER READ ABOUT 20-40 POINT HIGHER THAN THE HOSPITAL'S DEVICE ON (B)(6), 2010: THE SPECIFIC RESULTS WERE NOT REPORTED. THE PATIENT WAS UNABLE TO PROVIDE INFORMATION REGARDING THE TIME DIFFERENCE BETWEEN THE REPORTED RESULTS COMPARED TO THE HOSPITAL'S DEVICE AND IF THE TEST STRIPS WERE IN GOOD CONDITION. THE PATIENT CLAIMED THAT HE DEVELOPED HIGH BLOOD GLUCOSE AS A RESULT OF THE REPORTED ISSUES AND THAT HE REPORTEDLY RECEIVED INSULIN TREATMENT AT THE HOSPITAL ON (B)(6), 2010. IT IS UNKNOWN IF HE HAD DEVELOPED PHYSICAL SYMPTOMS OF HYPERGLYCEMIA AND HOW HIGH HIS BLOOD GLUCOSE LEVELS WERE AT THE HOSPITAL. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, ALL THE REPORTED ISSUES WERE NOT RESOLVED WITH CUSTOMER SERVICE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE PATIENT'S ALLEGATION OF INACCURATE HIGH METER RESULT CORRELATED WITH THE PATIENT'S TREATMENT AT THE HOSPITAL. IN ADDITION, THE REPORTED BUTTON AND DISPLAY ISSUES DO NOT IMPACT THE PATIENT'S ABILITY TO TEST. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE BUTTON, DISPLAY, AND INACCURACY ISSUES WERE NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR