BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT MINI METER

    MDR report key: 2749337 · Received September 18, 2012

    Report

    Report Number
    2939301-2012-10748
    Event Type
    Injury
    Date Received
    September 18, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 17, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP : ON (B)(6) 2012, THE PATIENT CONTACTED LIFESCAN (LFS) BACK AND THE CUSTOMER CARE ADVOCATE (CCA) WAS ABLE TO OBTAIN THE FOLLOWING INFORMATION: THE PATIENT CONTROLS HER DIABETES BY DIET AND SHE TAKES 2 PILLS OF METFORMIN XR 1000MG BEFORE GOING TO BED. SHE USUALLY TESTS HER BLOOD GLUCOSE 1-2X A DAY, WHICH IS BEFORE OR AFTER LUNCH. SHE ALWAYS TESTS IF HER BLOOD GLUCOSE FEELS LOW. ON (B)(6) 2012 AT 2:00PM THE PATIENT TESTED HER BLOOD GLUCOSE WITH HER ONE TOUCH SELECT MINI METER AND OBTAINED A 14.3 MMOL/L ( 257 MG/DL). THE 14.3 MMOL/L WAS THE LAST READING THE PATIENT HAD TAKEN PRIOR TO DEVELOPING SYMPTOMS OF DIZZY AND SHAKY ON (B)(6) 2012 AT 10:00AM. WHEN THE PATIENT HAD DEVELOPED THE SYMPTOMS SHE TESTED HER BLOOD GLUCOSE ON A NON-LFS METER AND OBTAINED AND OBTAINED A 2.5 MMOL/L ( 45 MG/DL) AND THEN IMMEDIATELY TESTED ON HER ONE TOUCH SELECT MINI METER AND OBTAINED A 15.6 MMOL/L( 280 MG/DL). AFTER EATING SUGAR, THE PATIENT FELT BETTER AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR TEST HER BLOOD GLUCOSE THE REST OF THE DAY. THE CLASSIFICATION OF THE COMPLAINT REMAINS THE SAME AS AN ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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.

    Description of Event or Problem · 1

    THE LAY REPORTER CONTACTED LIFESCAN (LFS) HUNGRY ON (B)(6) 2012 ALLEGING HIGH READINGS ON HER DAUGHTER'S ONE TOUCH SELECT MINI METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND IS WAITING FOR THE CUSTOMER SERVICE ADVOCATE (CCA) TO CONTACT THE PATIENT TO ASK THE FOLLOW UP QUESTIONS. THE FOLLOWING IS BASED ON THE INITIAL CALL THAT WAS PLACED ON (B)(6) 2012: THE REPORTER MENTIONED THAT ON (B)(6) 2012 AT AN UNSPECIFIED TIME THE PATIENT HAD DEVELOPED SYMPTOMS OF FEELING DIZZY AND SHAKY. THE PATIENT THEN TESTED ON HER ONE TOUCH SELECT MINI METER AND OBTAINED A 16.5MMOL/L ( 297 MG/DL) AND THEN TESTED ON NON-LFS METER AND OBTAINED A 2.5MMOL/L ( 45 MG/DL). THE RESULTS WERE DONE WITHIN MINUTES APART FROM ONE ANOTHER. THE PATIENT ATE SOME SUGAR AFTER TESTING AND FELT BETTER SHORTLY AFTER EATING. THE PATIENT DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. THE TEST STRIPS WERE NOT EXPIRED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO OBTAIN THE PATIENT'S DIABETES REGIMEN, READINGS PRIOR TO THE SYMPTOMS AND WHETHER THE PATIENT TESTED AFTER SELF-TREATMENT. THE PRODUCT WAS REPLACED AND REQUESTED BACK. THE COMPLAINT IS BEING REPORTED SINCE THE REPORTER ALLEGED THAT DUE TO THE ALLEGEDLY HIGH READING, THE PATIENT HAD DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SELF-TREAT WITH FOOD.

    Description of Event or Problem · 1

    (B)(4) - DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS (PA) RESPECTIVELY ON (B)(4) 2012 WITH THE FOLLOWING FINDING: THE METER PASSED TESTING WITH NO FAULTS FOUND. THE TEST STRIPS ALSO PASSED TESTING WITH NO FAULTS FOUND. RETAINS ALSO PASSED TESTING WITH NO FAULTS FOUND. THE PATIENT ALSO RETURNED TEST STRIP VIAL (LOT # 3232926) AND TEST STRIPS ALSO PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SELECT MINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3262092

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Life Threatening| R