BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IH-1000 AUTOMATED ANALYZER SYSTEM

    MDR report key: 9556549 · Received January 7, 2020

    Report

    Report Number
    9610824-2019-00080
    Event Type
    Malfunction
    Date Received
    January 7, 2020
    Date of Event
    November 13, 2019
    Report Date
    January 26, 2021
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969952274
    PMA / PMN Number
    BK170019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE IH-1000 GAVE SEVERAL "LIQ (LIQUID) "- ERROR MESSAGES WHEN TESTING SAMPLES IN REVERSE TYPING WITH IH-CELL A1&B AS WELL AS ANTIBODY SCREENING TEST WITH IH-CELL II. THE CORRESPONDING TRACE FILES WERE COLLECTED AND ANALYZED. ACCORDING TO THE TRACE FILE ANALYSIS, THE LIQ INTERPRETATIONS WERE CONFIRMED AND JUSTIFIED. IT WAS NOTICED THAT THE LIQ MESSAGE WAS GIVEN BECAUSE THE CELLS WERE DISPENSED INCORRECTLY (MISSING VOLUME) ON THE BLOOD GROUP TEST AND ANTIBODY SCREENING TEST. FURTHERMORE, THE RESULTS IMAGES CONFIRMED THAT NO CELLS WERE DISTRIBUTED INTO THE WELLS IN CASE OF THE LIQ ERROR. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING THE IH-1000 STATED, "ABO NOT INTERPRETABLE" AND NO INCORRECT RESULT WAS RELEASED. THE ERROR MESSAGES REQUIRED AN USER INTERACTION SO THAT IT COULD NOT LEAD TO A MISTYPING. BASED ON THE IMAGES OUR TECHNICAL SUPPORT ASSUMED A DIFFERENTIAL PRESSURE INSIDE THE INTERMEDIATE TANK AS A POSSIBLE CAUSE, HENCE IT WAS AN ISSUE REGARDING CUSTOMER SPECIFIC IH-1000 NOT A REAGENT RELATED ISSUE. THIS DIFFERENTIAL PRESSURE MAY AFFECT THE SAMPLING AND THE DISPENSING. THEREFORE, A BIO-RAD TRAINED FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE TO ADDRESS THE ISSUE. THE ENGINEER STATED THAT THE PUMP INTERMEDIATE TANK FILTERS WERE REPLACED. THE CUSTOMER HAS NOT HAD ANY FURTHER LIQ ISSUES SINCE THE INITIAL EVENT. A REVIEW OF THE BATCH RECORD DOCUMENTATION OF THE AFFECTED REAGENT IH_CELL I-II SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVE INFLUENCES ON THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. AS THE ISSUE HAS BEEN RESOLVED AFTER THE FIELD SERVICE ENGINEER VISITED THE CUSTOMER, NO FURTHER INVESTIGATIONS OR ACTIONS WERE NECESSARY. OUR INITIAL REPORT WAS ISSUED FOR THE IH-CELL I-II. SINCE THE ISSUE TURNED OUT TO BE INSTRUMENT-RELATED, OUR FINAL REPORT HAS BEEN ISSUED FOR THE IH-1000. DURING THE COMPLAINT INVESTIGATION IT BECAME EVIDENT THAT THE EVENT NOT ONLY OCCURED ON THE STATED DATE OF EVENT BUT ALSO ON A SECOND OCCASION, ON (B)(6) 2019. AN INTERNAL QUALITY NOTIFICATION HAS BEEN RAISED BECAUSE THIS SECOND DATE OF EVENT WAS NOT REPORTED TO FDA.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IH-1000 GAVE AN "LIQ"-ERROR WHEN HE TESTED A SAMPLE IN REVERSE CELLS AND IN IH-CELL II. THIS ERROR OCCURED WITH TWO DIFFERENT SAMPLES. LOG FILES FROM THE INSTRUMENT WERE COLLECTED FOR FURTHER REVIEW. INVESTIGATION OF THE INSTRUMENT AS WELL AS THE AFFECTED PRODUCT IH-CELL I-II IS STILL ONGOING. AN INTERNAL QUALITY NOTIFICATION HAS BEEN RAISED FOR EXCEEDING THE REQUIRED REPORTING DEADLINE TO FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24839 IH-1000 AUTOMATED ANALYZER SYSTEM IH-1000 (AUTOMATED ANALYZER SYSTEM) KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8939011 07611969952274

    Patients

    Seq Age Sex Outcome Treatment
    1 IH-1000, SN (B)(6).| IH-CELL A1&B, LOT 8939011.| IH-CELL I-II, LOT 8939011.