BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 1900309 · Received November 16, 2010

    Report

    Report Number
    2939301-2010-09907
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 4, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    11/16/2010: 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 FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED. THE 510(K) # IS K073231.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 11/17/2010. 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

    FOLLOW UP # 2/SUPPLEMENTAL REPORT TEXT- 12/10/2010: THE LAY USER/PATIENT'S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON NOVEMBER 4, 2010, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRALINK METER READ INACCURATELY HIGH COMPARED TO HIS EXPECTED RESULT. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AS BELOW. THE ALLEGED ISSUE BEGAN ON (B)(6) 2010 AT 345PM. THE PATIENT REPORTED A BLOOD GLUCOSE RESULT OF "140 MG/DL" WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH HUMALOG INSULIN, BASED ON BLOOD GLUCOSE RESULT AND DIET. IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK AT THE TIME OF THE ALLEGED ISSUE. AT 415PM THAT SAME DAY, THE PATIENT CLAIMED HE FELT SYMPTOMS OF SHAKY, CLAMMY, WEAKNESS AND BLURRED VISION. THE PATIENT TOOK FOOD AND/ OR DRINK AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE CCA WALKED THE PATIENT THROUGH A CONTROL SOLUTION TEST WHICH FELL WITHIN THE CONTROL RANGE FOUND ON THE VIAL OF TEST STRIPS. REPLACEMENT PRODUCTS WERE STILL SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Description of Event or Problem · 1

    TPN FOUND TO BE OFF; PUMP SHUT DOWN IMPROPERLY.

    Description of Event or Problem · 1

    THE LAY REPORTER/ HUSBAND CONTACTED LFS ON (B)(6) 2010 ALLEGING INACCURATE HIGH READINGS ON HIS WIFE'S ONE TOUCH VITA METER. THE REPORTER MENTIONED THAT HIS WIFE COMPARED HER TO ANOTHER METER IN THE PHARMACY TODAY AND THEY NOTICED A DIFFERENCE IN THE READINGS. AT NOON ON (B)(6) 2010, THE PATIENT OBTAINED A 130 MG/DL ON THE LFS AND ON THE OTHER METER IN THE PHARMACY , THE PATIENT'S BLOOD GLUCOSE WAS 144 MG/DL AT 12:08PM. APPROXIMATELY 10 MINUTES LATER, THE PATIENT DEVELOPED SYMPTOMS OF FEELING HOT, SWEATY AND FELL DOWN. THE PATIENT THEN SELF-TREATED WITH SUGAR, INSTEAD OF TAKING HER "NORMAL" DOSAGE OF INSULIN. THE PATIENT DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. THE PATIENT DID A BACK TO BACK TEST OVER THE PHONE WITH THE CUSTOMER CARE ADVOCATE (CCA) AND OBTAINED A 220 MG/DL AND A 223 MG/DL. THE HUSBAND WAS UNCOMFORTABLE WITH THE METER AND WANTED A REPLACEMENT METER. HE FELT THAT HIS WIFE COULD POTENTIALLY TAKE MORE INSULIN THAN NEEDED IF THE METER IS INACCURATE. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED AND THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE METER WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGEDLY OBTAINED A HIGH READING AND SHORTLY LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SELF-TREAT WITH FOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3052608

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R