BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1901660 · Received November 17, 2010

    Report

    Report Number
    2939301-2010-10051
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Report Date
    November 9, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 12/02/2010. 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

    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; 510(K)# IS K073231.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ABSTRACT TITLED "TRANSVENOUS CEMENT LEAKAGE INTO THE RIGHT ATRIUM AND CONSECUTIVE MYOCARDIAL INJURY DURING CEMENT AUGMENTED DORSAL SCREW-ROD FIXATION OF A TH12 FRACTURE", THAT: A (B)(6) WOMAN WAS TREATED FOR A COMPLEX TH12 FRACTURE. THIS FRACTURE WAS ALREADY PRE-TREATED IN A DIFFERENT HOSPITAL WITH TRAN SPEDICULAR KYPHOPLASTY AND A DORSAL SCREW-ROD INSTRUMENTATION TH11 TO L1. DUE TO A SEVERE OSTEOPOROSIS, THERE WAS DISLOCATION OF THE INTERNAL OSTEOSYNTHESIS, WHICH MADE AN OPERATIVE REMOVAL OF THE COMPLETE SYSTEM NECESSARY. IN THE FOLLOWING COURSE, A FURTHER SINTERING OF THE AUGMENTED TH12 FRACTURE COULD BE SEEN, THAT LEAD TO A FRAGMENT DISLOCATION INTO THE SPINAL CANAL AND CONSECUTIVE COMPRESSION OF THE SPINAL CORD. FINALLY, WE SAW THE INDICATION FOR A DORSAL INSTRUMENTATION TH10/11 TO L1/2 WITH CEMENT AUGMENTED PEDICLE SCREWS AND LAMINECTOMY OF TH12 FOR DECOMPRESSION OF THE SPINAL CORD. THE PATIENT RECOVERED FROM THESE PROCEDURES COMPLETELY, WITHOUT ANY NEUROLOGICAL DEFICIT. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE INACCURATE ERRATIC WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3056295

    Patients

    Seq Age Sex Outcome Treatment
    1