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

Model Number U701

Device Problem False Negative Result (1225)

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

Event Date 08/08/2022

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant negative results for one patient sample tested for erythrocytes on a cobas u 701 microscopy analyzer.The initial erythrocytes result measured from the sample was negative.The patient sample was measured again and the sample was found to be "full of erythrocytes." it is not known if the questionable result was reported outside of the laboratory.

Manufacturer Narrative

Based on the system log files, the cuvette filling was acceptable.The provided data did not indicate any software issues.The field service engineer performed some filling position adjustments on the centrifuge and microscope.The pipetting filling position was correct.No further investigation was possible as the patient sample is no longer available for investigation.The issue did not re-occur.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: 15352299
• MDR Text Key: 305698133
• Report Number: 1823260-2022-02722
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 11/07/2022

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: 08/15/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 10/12/2022
• Supplement Dates FDA Received: 11/07/2022
• 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