BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3242977 · Received July 23, 2013

    Report

    Report Number
    3008382007-2013-20814
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 4, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS HAVE PASSED ALL 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (08/08/2013)-DEVICE EVALUATION: THE ANALYSIS OF THE SUBJECT METER WAS COMPLETED ON 08/03/2013 BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE REPORTED COMPLAINT COULD NOT BE REPRODUCED DURING INVESTIGATION. THE METER FUNCTIONED NORMALLY AND NO ISSUES WERE FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH VERIOIQ METER READ INACCURATELY COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION, SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE FOR ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT SHE OBTAINED THE SUBJECT METER IN (B)(6) 2013. THE PATIENT CLAIMED THAT DURING 9 DAYS OF TESTING WITH THE SUBJECT METER, SHE EXPERIENCED FOUR ¿HYPOGLYCEMIA¿S¿ ON UNSPECIFIED DATES/TIMES. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF SHAKY AND SWEATY. IN RESPONSE TO THE SYMPTOMS, THE PATIENT STATED SHE WOULD DRINK SODA AND CONFIRMED SHE WOULD FEEL BETTER AFTERWARDS. THE CSR NOTED BLOOD GLUCOSE READINGS OF ¿2.6, 4.3, 3.3 AND 3.1 MMOL/L¿ IN THE METER MEMORY. IT IS NOT KNOWN IF THE PATIENT OBTAINED THESE RESULTS AT THE TIME OF THE LOW BLOOD GLUCOSE EXCURSIONS. AT THE TIME OF THE CALL, THE PATIENT PROVIDED READINGS OBTAINED WITH THE SUBJECT METER ON TWO OF THE OCCASIONS SHE EXPERIENCED THE LOW BLOOD GLUCOSE EXCURSIONS. ON AN UNSPECIFIED DATE IN (B)(6) 2013, THE PATIENT CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿7.8 MMOL/L¿ IN THE MORNING, ¿11 MMOL/L¿ IN MID-DAY, ¿9 MMOL/L¿ EVENING AND AFTER DINNER AND ¿3.1 MMOL/L¿ BEFORE GOING TO BED. ON A DIFFERENT DAY SHE OBTAINED BLOOD GLUCOSE READINGS OF ¿7.5 MMOL/L¿ IN THE MORNING, ¿9 MMOL/L¿ IN MID-DAY, ¿8.4 MMOL/L¿ IN THE AFTERNOON, ¿3.3 MMOL/L¿ AFTER DINNER AND ¿13 MMOL/L¿ IN THE EVENING. IT IS NOT KNOWN IF THE PATIENT FELT READINGS OBTAINED WITH THE SUBJECT METER PRIOR TO THE ONSET OF SYMPTOMS WERE INACCURATELY HIGH. THE PATIENT INFORMED THE CSR THAT SHE MANAGES HER DIABETES WITH INSULIN. THE PATIENT DENIED TAKING ANY INCREASED DOSE OF INSULIN IN RESPONSE TO THE METER READINGS. AT THE TIME OF TROUBLESHOOTING, THE PATIENT CONFIRMED THE TEST STRIPS APPEARED IN GOOD CONDITION AND WERE NOT EXPIRED OR OPENED PAST THEIR DISCARD DATE. THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER AND TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER OBTAINING ALLEGED INACCURATE RESULTS WITH THE LFS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342912 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R