MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS U 601 URINE ANALYZER; AUTOMATED URINE ANALYZER

Model Number U 601

Device Problem Patient Data Problem (3197)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer alleged a patient sample mismatch issue between the cobas u 601 urine analyzer and the cobas u 701 microscopy analyzer.Neither the u 701 analyzer nor a similar device is sold in the united states.The customer alleged that during the processing of 2 patient samples the analyzers mixed up the results of the 2 different patient samples when the same rack id and position was used.Based on the pictures provided from the customer, the results from the 2 samples on rack (b)(6) in position 2 are interchanged.The sample id of the affected results is (b)(6).The results from the u 701 analyzer shows results that do not match the results on the u 601 analyzer but the results have the same sample id of (b)(6).The customer stated they did not reuse the same patient sample id for these tests.Based on the information provided from the customer, a hardware alarm occurred during the measurement for the 1st patient sample and the measurement was stopped.At this point, the u601 analyzer should have been initialized.If the initialization process had been allowed to complete normally, the order to the results in question would have produced an error by the end of the process.In this case, the customer manually removed the rack prior to performing the initialization process.Because of this, the u 701 analyzer continued the order and no error was received.The rack was put back on the instrument after the initialization was completed and a new process was started.The u 601 analyzer created a new order with new results because there weren¿t any orders to choose from.The u601 part of the previous order was finished so choosing the previous order to continue was not an option.The rack then arrived at the u 701 analyzer where 2 orders were accepted; based on the specifications of the u 701 analyzer, the oldest order was selected.Based on the data available, the issue occurred due to the customer removing the rack and not allowing the initialization process to complete as normal.The sample mismatch occurred because there was an ongoing order in the u 601 instrument for that specific sample id, rack id and tube position combination.This order was interrupted by the hardware alarm and the customer initialized the instrument after manually removing the rack.This prevented the rack from arriving to the u 701 bar-code reader.Since the rack did not arrive to the bar-code reader, no error was received.There was no allegation that an adverse event occurred.The u 701 analyzer serial number was (b)(4).Investigations are ongoing.

Manufacturer Narrative

The field application specialist (fas) visited the customer site on (b)(4) 2018 and was able to reproduce the issue using two tubes with different sample ids.Investigations are ongoing.

Manufacturer Narrative

The customer provided the steps they used to reproduce the issue on the u701 instrument.The investigation attempted to reproduce the issue using the same steps, however they were not successful.A similar issue was seen when the barcode reader on the u701 instrument did not read the barcode.However, this is not an error.If a barcode is unreadable, the only way to choose an order is by rack id and tube position.To create this situation, an unfinished order is waiting in the system and the rack which was used to create it is reinserted into the instrument.An unfinished order can occur when a rack is removed manually which causes the u701 instrument to not measure it.Re-using a rack can cause issues.Re-using racks is not based on time, it depends on the completion of previous measurements from that rack.If there are unfinished orders in the system, those orders will be selected even if days have passed.This can be avoided by not leaving unfinished orders in the system.If a rack is removed manually, the orders should always be deleted before re-using the rack.The investigation stated that the steps the customer used to reproduce the issue and the initial event were not the same.The customer had indicated that they reproduced the issue using 2 different sample ids however based the data provided, the same samples ids were used.The customer did not provide the instrument logs to show which message prompted them to remove the rack manually.The issue could not be reproduced by the investigation.This "mismatch" can happen with 2 different sample id barcodes if the u701 instrument cannot read the barcode when the rack is re-used a 2nd time.In this case, the rack id and tube position identification was valid due to the unreadable barcode.Based on the information provided, the u701 instrument is operating per specification.

Manufacturer Narrative

Product problem was corrected.

• Brand Name: COBAS U 601 URINE ANALYZER
• Type of Device: AUTOMATED URINE ANALYZER
• 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: 7181561
• MDR Text Key: 97738180
• Report Number: 1823260-2018-00117
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K012397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/20/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: U 601
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 12/14/2017; 12/14/2017; 12/14/2017
• Supplement Dates FDA Received: 02/09/2018; 03/19/2018; 09/20/2018
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1