MAUDE Adverse Event Report: ROCHE DIAGNOSTICS URISYS 1100; AUTOMATED URINE ANALYZER

Model Number U1100

Device Problems No Device Output (1435); Communication or Transmission Problem (2896)

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

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

The instrument was requested for investigation.The customer confirmed the operator put the patient id in correctly.The customer is using the correct cable.The investigation is ongoing.

Event Description

The initial reporter complained of a software issue with a urisys 1100 urine analyzer, software version 6.6.The customer stated the analyzer did not transmit a patient result from (b)(6) 2021.On (b)(6) 2021 positive qc was run and the qc results were transmitted with patient id (b)(6)from (b)(6) 2021.

Manufacturer Narrative

It was noted that a barcode scanner is used for patient samples; the interface is bidirectional.The customer provided four printouts from (b)(6) 2021 and (b)(6) 2121.The customer states these four printouts belong to qcs from these two days.There is no printout available for patient id (b)(6) which the customer states was not transmitted nor printed on (b)(6) 2021 and was transmitted on the following day as a qc result.The patient id number appears on the printouts from (b)(6) 2021 but it cannot be found in the file containing qc data and the trace log, therefore, a sample mismatch cannot be confirmed.Based on a review of the information provided, the printed result from (b)(6) 2021 corresponds to entries within the trace log.The printed data from (b)(6) 2021 have no entries within the trace log.The customer's allegation could not be reproduced.The cause of the event could not be determined.

• Brand Name: URISYS 1100
• Type of Device: AUTOMATED URINE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12332042
• MDR Text Key: 267450492
• Report Number: 1823260-2021-02400
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 00075537253564
• UDI-Public: 00075537253564
• Combination Product (y/n): N
• PMA/PMN Number: K033548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

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: U1100
• Device Catalogue Number: 03617556001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/17/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1