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

Model Number U 601

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable glucose (urine) results for 1 patient sample on a cobas u 601 urine analyzer.The initial result was positive (1000 mg/dl).The repeated result was negative.A numeric value for the repeated result was not provided.The initial (positive) result was believed to be correct.The results were reported outside of the laboratory.The reagent lot number and expiration date were requested but not provided.

Manufacturer Narrative

The investigation determined that a different sample run the day before had a barcode read error and glucose was measured resulting in a negative value.Other orders for this sample were still pending and the analysis had not been completed.The next day the complained sample was tested in the same rack and position as the sample that had run the day before that had not finished being analyzed.The analyzer recognized there was a pending order for the rack and position, and then assigned new results from the complained sample to the same pending order.The new glucose result was positive.The investigation determined customer did not manage the pending orders before starting a measurement cycle.Per product labeling "caution! sample mismatch due to pending sample orders.Having pending sample orders in the order list may lead to sample mismatch.Delete any pending sample orders from the order list before starting the measurement.On the overview work area, check that there are no pending sample orders in the task list.".

• 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
• MDR Report Key: 11059846
• MDR Text Key: 244564213
• Report Number: 1823260-2020-03346
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• PMA/PMN Number: K012397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

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: U 601
• Device Catalogue Number: 06390498001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 11/30/2020
• Supplement Dates FDA Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1