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 12/28/2022

Event Type  malfunction  

Manufacturer Narrative

The developer's review of the provided data determined that two cuvettes became stacked on top of each other.It was found that the cuvette containing the sample from position 2 became stuck in the microscope arm and the cuvette containing the sample from position 3 was placed on top of it.This caused the analyzer to measure the bottom cuvette while using the top cuvette's sample id.The investigation is ongoing.

Event Description

There was an allegation of incorrect results due to an analyzer sample mismatch for 2 patient samples on a cobas u 701 microscopy analyzer with software version 2.3.8.The customer alleged that two different patient samples were run in the same sample rack in positions 2 and 3 and the results were mismatched by the analyzer.The customer repeated both samples individually and confirmed that the results initially resulted under the incorrect sample ids.No incorrect results were reported outside of the laboratory.

Manufacturer Narrative

It was recommended to the customer to check and exchange the microscope arm as necessary and to perform set-up for the cuvette pusher at the microscope position.It was also recommended to check the cuvette fill position to ensure that the probe removes overflow correctly, as overflow can cause cuvettes to stick and prevent proper disposal.The investigation determined that the root cause of the event is consistent with a hardware issue or maladjusted hardware.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16218652
• MDR Text Key: 308913414
• Report Number: 1823260-2023-00204
• 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: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• 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
• Date Manufacturer Received: 04/06/2023
• 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