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

Model Number U701

Device Problem Incorrect Measurement (1383)

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

Event Date 11/25/2021

Event Type  malfunction  

Event Description

The initial reporter alleged a software issue on a cobas u 701 microscopy analyzer.The customer initially tested a patient sample and the red blood cells (rbc) result was 1059.52/ul and the white blood cells (wbc) result was 124/ul.The customer tested the sample by artificial microscopy and the rbc result was < 1/ul.The customer repeated the sample on the analyzer and the rbc result was < 1.00/ul and the wbc result was 1.98/ul.The customer noted the initial results were similar to the previous level 2 qc results for rbc and wbc, however, on the day of the event the level 2 qc results for rbc and wbc were both < 1/ul.The customer alleges the initial results were qc results and not the actual results for the patient sample.

Manufacturer Narrative

The logfiles from the u701 instrument were reviewed and no issues were identified.The mechanical flow was correct and there were no false rack movements.A review of the results from the customer's laboratory information system (lis) confirms the customer's allegation.The result from the u701 instrument was highly positive.The five samples that were run after the one sample in question do not show any signs of a sample mismatch as all results were similarly negative.After these 5 samples, qc was performed with passing results.Based on the data provided, the specific cause of the event could not be determined.

Manufacturer Narrative

The component code was updated.

• 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: 13042164
• MDR Text Key: 284209374
• Report Number: 1823260-2021-03777
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 04/18/2022

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: 11/25/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 01/17/2022; 03/28/2022
• Supplement Dates FDA Received: 02/04/2022; 04/18/2022
• 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