BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2253096 · Received September 19, 2011

    Report

    Report Number
    2939301-2011-09159
    Event Type
    Injury
    Date Received
    September 19, 2011
    Date of Event
    September 2, 2011
    Report Date
    September 6, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4), 2012 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED; HOWEVER, A SECONDARY ISSUE WAS NOTED WHERE THE METER WAS FOUND TO HAVE A LOOSE BATTERY CONTACT AND A DIRTY METER DISPLAY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS 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. 510(K) # IS K082590.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRAPING METER IS EXPERIENCING A DISPLAY ISSUE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE REPORTER THAT ON (B)(6) 2011 AT 7:30PM, THEY ALLEGEDLY DISCOVERED THE "LINE THROUGH THE DISPLAY" ON THE SUBJECT METER, MAKING THE SEGMENTS UNREADABLE. THE REPORTER STATED THAT THE PATIENT MANAGES HER DIABETES WITH THE INSULIN PUMP AND DENIED MAKING ANY CHANGES TO THE PATIENT'S NORMAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE REPORTED ISSUE. IT IS NOT KNOWN IF THE PATIENT DEVELOPED ANY SYMPTOMS, BUT THE REPORTER CLAIMED THAT THE "PUMP GAVE AN UNSPECIFIED AMOUNT OF BOLUS, BUT COULD NOT SEE THE READING BECAUSE OF THE LINE" CAUSING THE PATIENT "TO GO LOW". THE CCA WAS INFORMED BY THE REPORTER THAT ON THE SAME DAY AND TIME THAT THE REPORTED ISSUE OCCURRED, THE PATIENT WAS TAKEN TO URGENT CARE/CLINIC. IT IS NOT KNOWN IF THE PATIENT WAS TESTED ON ANOTHER DEVICE, BUT WAS TREATED WITH GLUCOSE TABLETS/GLUCOSE GEL AT THE CLINIC. DURING TROUBLESHOOTING, THE CCA NOTED THAT THERE WAS NO EVIDENCE OF MISUSE AND THAT THE PATIENT HAS A BACKUP METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH IT NOT KNOWN IF THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT RECEIVED MEDICAL TREATMENT AFTER THE ALLEGED PRODUCT ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3147655

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening