MAUDE Adverse Event Report: ROCHE DIAGNOSTICS URISYS 1800; AUTOMATED URINE ANALYZER

Model Number U1800

Device Problem Patient Data Problem (3197)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated the software on the analyzer was slow and the sample id printed out on the results was not the same as the sample id that was scanned.This occurred on 5-6 samples.One example was provided of a sample id of (b)(6) printing as (b)(6).The customer stated only one sample is tested at a time and the results could not cross to the lis.The printouts from the instrument are not reported and are normally just thrown away.No incorrect information or results were reported outside of the laboratory.There was no adverse event.The customer performed a reboot and manually ordered a sample and the sample id mismatch still occurred.Upon follow up, the customer stated she "thought she had the instrument working.".

Manufacturer Narrative

A specific root cause could not be identified.The customer stated they resolved the issue by cleaning the instrument, performing a reboot, and unplugging the barcode scanner then plugging it back in.The customer has had no further issues since these actions.The issue could also have been related to the barcode reader which is a third party product.

• Brand Name: URISYS 1800
• Type of Device: AUTOMATED URINE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7086045
• MDR Text Key: 95013114
• Report Number: 1823260-2017-02848
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

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: U1800
• Device Catalogue Number: 03285049001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/06/2017
• Supplement Dates Manufacturer Received: 11/21/2017
• Supplement Dates FDA Received: 12/19/2017
• 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