inforMED
MalfunctionJIL

COBAS U 601 URINE ANALYZER

Received Mar 30, 2023 · Event occurred Mar 2, 2023

Report 1823260-2023-01017 · MDR key 16648489

Device

Generic name

Automated Urine Analyzer

Manufacturer

Roche Diagnostics

Model number

U 601

Catalog number

06390498001

Lot number

NA

Product problems

  • Optical Problem
  • Missing Test Results
  • Optical Problem
  • Missing Test Results

Patient

Unknown

  • Insufficient Information
  • No Clinical Signs, Symptoms or Conditions
  • Insufficient Information
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE DEVICE, EVALUATION METHOD, EVALUATION RESULT AND EVALUATION CONCLUSION CODES WERE UPDATED.

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER CHECKED 'FLOWCONTROL' AND OTHER FILES FROM THE PROBLEM REPORT AND FOUND NO MISSED TUBES OR ERRONEOUS RACK BARCODES. MECHANICAL ADJUSTMENTS OF TUBE, RACK SENSORS AND RACK READING POSITIONS WERE OKAY. THE ROOT CAUSE OF THE COMPLAINED PHENOMENON WAS THAT THE U601 URINE ANALYZER DID NOT RECOGNIZE ONE OF THE RACKS BARCODE BUT THE CONNECTED U701 URINE ANALYZER DID AND THIS CAUSED THE SAMPLE MISMATCH. IN CASE THE RACK BARCODE CAN NOT BE READ BY ONE OF THE INSTRUMENTS, A SHIFT MAY HAPPEN WITH THE RESULTS. IN CASE THE CUSTOMER USES THE SYSTEM IN SEQUENCE MODE, THEY NEED TO MONITOR THE RESULTS/SAMPLE MISMATCH VERY OFTEN. IT IS VERY MUCH ADVISED TO UPGRADE TO VERSION 2.3.8. OF THE SOFTWARE (THE LATEST VERSION). THE ISSUE IS SOLVED IN SOFTWARE VERSION 2.3.8.

Description of Event or Problem

THE CUSTOMER ALLEGED SAMPLE MISMATCH WHILE WORKING IN A SEQUENCE MODE WITHOUT BARCODES ON THE COBAS 6500 U601 URINE ANALYZER USING SOFTWARE VERSION V2.3.7. THE CUSTOMER STARTED ROUTINE TESTING WITH A SAMPLE IDENTIFIED AS N1 AND RACK NUMBER: 0001 SO THAT TUBES IDENTIFIED AS N6-N10 WENT TO RACK NUMBER: 0002, TUBES IDENTIFIED AS N11-N15 TO RACK NUMBER: 0003, TUBES IDENTIFIED AS N16-N20 TO RACK NUMBER: 0004, AND TUBES IDENTIFIED AS N21-N25 WERE EXPECTED TO GO TO RACK NUMBER: 0005, BUT A MISMATCH OCCURRED. THE SAMPLE IDENTIFIED AS N25 WAS IN POSITION 3 OF THE RACK AND A SAMPLE IDENTIFIED AS N27 WAS IN POSITION 4. AS A RESULT, ALL OTHER NUMBERS WERE SHIFTED.