BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2881858 · Received December 20, 2012

    Report

    Report Number
    3008382007-2012-08736
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    December 5, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ((B)(4) 2012) DEVICE EVALUATION: THE SUBJECT METER HAS BEEN RETURNED TO LFS FOR EVALUATION ON (B)(4) 2012 AND COMPLETED ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND, THE COMPLAINT WAS NOT CONFIRMED. IF LFS OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AT THIS TIME, LFS CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH PING METER WAS DISPLAYING DATES IN THE FUTURE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO FOLLOW UP WITH THE REPORTER. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT WAS UNABLE TO RECALL WHEN THE ALLEGED ISSUE FIRST OCCURRED. THE PATIENT REPORTED USING NOVOLOG INSULIN PUMP THERAPY TO MANAGE HIS DIABETES. THE PATIENT REPORTED ON (B)(6) 2012 HE HAD AN INCREASED DOSE OF NOVOLOG INSULIN OF 20 UNITS. THE PATIENT REPORTED ON AN UNKNOWN DATE AND TIME HE FELT LETHARGIC AND THIRSTY. IT IS UNCLEAR IF THE SYMPTOMS OCCURRED PRIOR TO THE INCREASE IN MEDICATION OR AFTERWARDS. HOWEVER THE PATIENT DENIED RECEIVING FURTHER TREATMENT IN RESPONSE TO HIS SYMPTOMS. DURING THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THIS WAS NOT THE FIRST TIME THE METER HAD BEEN USED, AND IT WAS NOT THE FIRST USE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH A WALK THROUGH RETEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE METER HAS BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE COMPLAINT WAS NOT CONFIRMED. BASED ON THE PROVIDED INFORMATION AT THIS TIME, IT IS UNCLEAR HOW THE METER MEMORY ISSUE CAN LEAD TO THE PATIENT'S SYMPTOMS SINCE THE METER MEMORY DOES NOT AFFECT THE ABILITY TO TEST. THUS, THE LINKAGE BETWEEN THE REPORTED PRODUCT ISSUE AND THE ALLEGED INJURIES BY THE PATIENT REMAINS UNCLEAR. IN CONCLUSION, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE METER MEMORY ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3316487

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Life Threatening