BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 1970546 · Received January 25, 2011

    Report

    Report Number
    2939301-2011-00863
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 4, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    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 LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH PING METER WAS READING INACCURATELY ERRATIC. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN TWO WEEKS PRIOR TO CONTACTING LFS. ON AN UNSPECIFIED DATE/TIME, THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE RESULTS IN THE "200'S" AND "40 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN A FEW MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. THE PATIENT INDICATED SHE MANAGES HER DIABETES WITH INSULIN (VIA INSULIN PUMP); IT IS NOT KNOWN HOW OFTEN THE PATIENT TESTS HER BLOOD GLUCOSE. ACCORDING TO THE CSR'S DOCUMENTATION, IN RESPONSE TO THE ALLEGED ISSUE, THE PATIENT CONTINUED WITH HER USUAL DOSE OF MEDICATION ON (B)(6) 2011 AT 10AM; IT IS NOT KNOWN, HOWEVER, WHAT TYPE OF ACTION THE PATIENT TOOK PRIOR TO (B)(6) 2011. IT IS NOT SPECIFIED HOW MUCH INSULIN THE PATIENT ADMINISTERED AFTER THE ALLEGED ISSUE BEGAN AND IT IS NOT KNOWN IF THE PATIENT TESTED HER BLOOD GLUCOSE WITH ANOTHER DEVICE. THE PATIENT DENIED SHE DEVELOPED ANY SYMPTOMS AS A RESULT OF THE REPORTED METER ISSUE. PER CSR'S NOTES, ON (B)(6) 2011 AT 10AM, THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "29MG/DL" WITH THE EMERGENCY MEDICAL SERVICES' (EMS) METER, WAS ADMINISTERED IV GLUCOSE AS TREATMENT BY EMS, AND WAS SOON AFTER TRANSPORTED TO THE HOSPITAL. REASON FOR CONTACTING EMS IS NOT KNOWN AND IT IS NOT SPECIFIED WHAT THE PATIENT'S BLOOD GLUCOSE RESULT WAS PRIOR TO CONTACTING EMS. IT IS NOT KNOWN WHEN THE PATIENT WAS RELEASED FROM THE HOSPITAL. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE CORRECT UNIT OF MEASUREMENT ON THE SUBJECT METER AND NOTED THAT THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER'S MANUAL) SAMPLE SITE. THE CSR ALSO NOTED THE PATIENT WAS USING EXPIRED TEST STRIPS AT THE TIME OF THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH IT WAS DISCOVERED THE PATIENT WAS USING EXPIRED TEST STRIPS AT THE TIME OF THE ALLEGED ISSUE, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE READING ON THE SUBJECT METER, ADMINISTERED INSULIN BASED ON THE ALLEGED RESULT, AND WAS REPORTEDLY TREATED BY AN HCP FOR SEVER HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2513520

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Life Threatening| R