BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED BLOOD TYPING SYSTEM WITH AUTOMATIC BARCODE READER

    MDR report key: 12823 · Received April 19, 1994

    Report

    Report Number
    MW1001650
    Event Type
    Malfunction
    Date Received
    April 19, 1994
    Date of Event
    September 15, 1993
    Report Date
    March 24, 1994
    Manufacturer
    IBG SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 9/15/93 IT WAS DISCOVERED THAT AN A-POS UNIT, HAD INCORRECTLY BEEN TYPED AS O-POS BY THE AUTOMATED BLOOD GROUPING SYSTEM. THE ERROR WAS IMMEDIATELY REPORTED TO THE MFR FOR INVESTIGATION AND CORRECTION. ACCORDING TO THE MFR, THE FAILURE WAS SOLELY DUE TO A COMPONENT MALFUNCTION IN THE MICROPLATE READER. THE MFR REPLACED THE MICROPLATE READER AND SUBSEQUENTLY NOTIFIED FDA, CENTER FOR BIOLOGICS EVALUATION AND RESEARCH OFFICES OF THE FAILURE, AS WELL AS ISSUING A TECHNICAL BULLETIN TO ALL USERS REGARDING THE MALFUNCTION AND INTENDED SOFTWARE REVISIONS. ON 11/20/93 A FIRST-TIME DONOR WAS INCORRECTLY TYPED BY THE BLOOD GROUPING SYSTEM AS O-POS. THIS ERROR WAS DETECTED ON 11/26/93 DURING CROSSMATCH PROCEDURES. CONFIRMATORY TYPING FROM AN INTEGRAL TUBING SEGMENT REVEALED THE UNIT TO BE A-POS. IMMEDIATE INVESTIGATION OF THIS ERROR RULED OUT ANY TESTING ERRORS ON THE PART OF THE TECHNOLOGISTS; NO UNUSUAL PROBLEMS WERE ASSOCIATED WITH THE RUN NOR WERE OTHER TYPING DISCREPANCIES NOTED. RETESTING OF THE IN-LINE PILOT TUBE AND THE RETENTION SAMPLE YIELDED GROUP A, HOWEVER THE ORIGINAL EDTA SAMPLE HAD NOT BEEN RETAINED. A MISLABELED OR CONTAMINATED SAMPLE REMAINS A POSSIBILITY. DUE TO THIS ERROR AND OTHER UNRELATED EQUIPMENT FAILURES INVOLVING THE BAR CODE SCANNING WAND AND THE DIFFICULTIES EXPERIENCED OBTAINING BATCH DATA FROM THE ARCHIVE DISK, THE MFR WAS NOTIFIED. THE USE OF THE EQUIPMENT WAS DISCONTINUED ON 12/1/93 UNTIL A SATISFACTORY RESOLUTION TO THE MISTYPE ALONG WITH OTHER CONCERNS COULD BE ADDRESSED BY THE MFR. ON 12/2/93, THE MFR INDICATED THAT THEY COULD NOT IDENTIFY THE CAUSE OF THE ERROR AND POSED THAT A FAULTY DISK DRIVE OR SOME INTERNAL PC MALFUNCTION WAS PROBABLE. RPTR'S INFORMATION SYSTEMS DEPT CONDUCTED DIAGNOSTIC TESTING OF THE HARDWARE. NO MALFUNCTIONS WERE IDENTIFIED. THIS INFO WAS RELAYED TO THE MFR VIA PHONE AND LETTER. THE FINAL ANALYSIS BY THE BLOOD CENTER AND THE MFR DID NOT RESULT IN ANY DEFINITE CONCLUSIONS. DUE TO OUTSTANDING QUESTIONS ABOUT THE RELIABILITY OF THE INSTRUMENT AND CONCERNS ASSOCIATED WITH THE VENDOR'S ABILITY TO RESOLVE OTHER UNRELATED ISSUES, THE USE OF THE AUTOMATED BLOOD GROUPING SYSTEM HAS BEEN INDEFINITELY DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED BLOOD TYPING SYSTEM WITH AUTOMATIC BARCODE READER AUTOMATED BLOOD TYPING SYSTEM WITH AUTOMATIC BARCODE READER KSZ IBG SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other