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

Model Number U701

Device Problems Computer Software Problem (1112); Incorrect Measurement (1383)

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

Event Date 01/04/2023

Event Type  malfunction  

Manufacturer Narrative

The field service engineer verified the mechanical adjustment of the cuvette mechanism.The affected samples were re-processed.Medwatch initial reporter phone number was provided as: (b)(6).

Event Description

The initial reporter stated they are having issues with mismatched results on the cobas u 701 microscopy analyzer.The microscopy results from the u 701 do not correspond to the qualitative urinalysis values measured on the cobas u 601 analyzer for the same sample identifiers.Mismatched data occurred for 12 patient samples.Data for three affected patient samples were provided.Sample 1 results: u 601 results: erythrocytes = 3 +, leukocytes = negative.U 701 results: rbc = 2.6/ul, wbc = 14.5/ul.Sample 2 results: u 601 results: erythrocytes = negative.U 701 results: rbc = 15.84/ul.Sample 3 results: u 601 results: erythrocytes = 3 +, leukocytes = negative.U 701 results: rbc = < 1/ul, wbc = 232/ul.

Manufacturer Narrative

The provided data was analyzed by the developer and application team.There was no evidence provided which confirms or refutes a sample mismatch.The investigation could not identify a product problem.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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16241692
• MDR Text Key: 308926049
• Report Number: 1823260-2023-00229
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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
• Type of Report: Initial,Followup
• Report Date: 04/10/2023

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?: No
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 01/25/2023
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 04/10/2023
• 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