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

Model Number U701

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 11/10/2022

Event Type  malfunction  

Event Description

The initial reporter complained of a software issue with a cobas u 701 microscopy analyzer, software version 2.3.7.The customer alleged that the demographic information for 1 patient was not correct in the software of the analyzer.The demographic information for the patient was correct in the customer¿s laboratory information system (lis).The results were sent in the correct patient file from the lis.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

The investigation determined the user navigated through the pages but did not change the sample result.The result was validated, then the patient id was manually assigned and the result was manually sent to the customer's laboratory information system (lis).The investigation determined the instrument software worked correctly.The event was due to use error at the customer site.

• 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: 15945425
• MDR Text Key: 307912641
• Report Number: 1823260-2022-03942
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• 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: 12/19/2022
• 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