MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS U 701 MICROSCOPY ANALYZER; AUTOMATED URINALYSIS SYSTEM

Model Number U701

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The initial reporter received questionable white blood cell (wbc) count, red blood cell (rbc) count, bacteria and mucus results for one urine patient sample tested on a cobas u 701 microscopy analyzer.It is unknown if the initial results were reported outside of the laboratory.The reporter initially ran the urine patient sample at 7:43.The wbc count was 150.48/ul with a data flag; the rbc count was 708.40/ul with a data flag; the bacteria and mucus results were negative.The microscopic urine sediment did not match u 701 sediment which prompted the reporter to rerun the sample.The urine patient sample was rerun on the analyzer at 8:19.The wbc count was <1.00/ul; the rbc count was 4.40/ul; bacteria was +1 with a data flag and mucus was positive with a data flag.The level 2 qc was run with the same rack number as the urine patient sample in the initial testing.The qc was tested at 7:47.The wbc count was 144.54/ul with a data flag; the rbc count was 728.64/ul with a data flag; the bacteria and mucus results were negative.

Manufacturer Narrative

Based on the archive log files, the tube detection/rack position detection sensor had problems in the past.Based on the log analysis, the software worked correctly.There were no logical flaws discovered during the investigation.During measurement of the sample, a low sample volume warning message was issued by the analyzer.The low sample volume warning message is an indicator that something went wrong during the measurement.The developers investigated the provided material and confirmed the mismatch of the complained sample.The cause of the event could not be determined. .

• Brand Name: COBAS U 701 MICROSCOPY ANALYZER
• Type of Device: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14188303
• MDR Text Key: 299080684
• Report Number: 1823260-2022-01143
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: ASKU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U701
• Device Catalogue Number: 06390501001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 06/27/2022
• Supplement Dates FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1