BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VITA METER

    MDR report key: 1982513 · Received February 9, 2011

    Report

    Report Number
    2939301-2011-01242
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 25, 2011
    Report Date
    February 8, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (03/03/2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 2/SUPPLEMENTAL REPORT TEXT- 3/16/2011: THE LAY USER/PATIENT'S PRODUCTS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER AND TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. 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

    (B)(4). 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

    THE LAY USER / PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON HER ONE TOUCH VITA METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT MENTIONED THAT THE ALLEGED HIGH READINGS BEGAN ON (B)(6) 2011. DUE TO THE ALLEGED ISSUE, THE PATIENT INCREASED HER INSULIN ON HER OWN TO 4 UNITS. THE PATIENT DOES NOT RECALL WHAT HIGH READINGS SHE HAD OBTAINED. AT AN UNSPECIFIED TIME LATER AFTER TAKING THE INCREASE DOSAGE OF INSULIN, SHE DEVELOPED SYMPTOMS OF "SHIVERS", SWEATING AND A STOMACHACHE. THE PATIENT DID NOT SELF-TREAT; HOWEVER, HER PHYSICIAN GAVE HER A BIETA AND WENT BACK TO HER USUAL INSULIN REGIMEN. HER SYMPTOMS LASTED FOR 14 DAYS. THE PATIENT DID ATTEMPT TO TEST HER BLOOD GLUCOSE DURING THE TIME OF EXHIBITING THE SYMPTOMS; HOWEVER, DOES NOT RECALL THE READINGS. ON (B)(6) 2011 THE PATIENT TESTED ON ANOTHER DEVICE AT 6:00PM AND OBTAINED A 236 MG/DL. THE PATIENT THEN TESTED ON HER LFS METER AND 6:30PM AND A 308 MG/DL AND A 236 MG/DL. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. A QUALITY CONTROL TEST WAS DONE AND THE TEST STRIPS PASSED USING THE CONTROL SOLUTION. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE HIGH READINGS, SHE TOOK AN INCREASE DOSAGE OF INSULIN AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2989295

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening| R