BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 3053123 · Received April 11, 2013

    Report

    Report Number
    3008382007-2013-07596
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 18, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K072543
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (6/21/2013).THE PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED ON 5/17/2013 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 5/25/2013 AND 5/24/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON 4/24/2013 FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. IN ADDITION, PERFORMANCE TESTING WITH BLOOD WAS PERFORMED ON THE RETAIN TEST STRIPS ON 5/1/2013. THE RETAIN TEST STRIPS PASSED THE PERFORMANCE TESTING WITH BLOOD. 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

    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

    ON (B)(6) 2013, THE LAY USER/PATIENT'S SON (REPORTER) CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HIS FATHER'S ONETOUCH SELECT METER WAS DISPLAYING AN ERROR 5 MESSAGE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE REPORTER ALLEGED THAT THE ISSUE BEGAN IN THE EVENING OF (B)(6) 2013. THE PATIENT REPORTEDLY MANAGES HIS DIABETES WITH INSULIN; IN THE MORNING 12 UNITS OF "GENSULIN R" AND IN THE EVENING 10 UNITS OF "GENSULIN R" AND 12 UNITS OF "GENSULIN N." FOLLOWING THE ALLEGED METER ISSUE, THE PATIENT REPORTEDLY CONSUMED HIS DINNER THAT EVENING AND ADMINISTERED HIS USUAL DOSES OF INSULIN AND CONSEQUENTLY, THE PATIENT REPORTEDLY LATER DEVELOPED A SYMPTOM OF SWEATING AT APPROXIMATELY 4AM (ON (B)(6)). IT IS NOT KNOWN WHAT TYPE OF TREATMENT THE PATIENT RECEIVED (IF ANY) AFTER THE REPORTED METER ISSUE OCCURRED. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME, THE TEST STRIPS WERE NOT PASSED THE EXPIRY DATE, THE PATIENT WAS USING THE PROPER TESTING PROCEDURE (PER OWNER'S BOOKLET RECOMMENDATION) AND THE TEST STRIP COMPLETELY DREW IN THE PATIENT'S BLOOD SAMPLE. HOWEVER, THE ALLEGED METER ISSUE REMAINS UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156391 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3212158

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening