MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR 10-TEST UX 100T; METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)

Catalog Number 11544373191

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

The reporter's product was requested for investigation, but the customer no longer has the test strips.This event occurred in (b)(6).

Event Description

The initial reporter stated they received a discrepant erythrocytes result for one patient sample tested with combur 10 ux test strips.A sample from the patient was tested with the combur 10 ux test strip and a visual read of the strip determined the sample was negative for erythrocytes.The patient went to the hospital and a second sample was collected from the patient and tested approximately 6 hours later using an unknown method, resulting with a 4+ value for erythrocytes.The patient did not eat or drink in between the two sample collections.

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: COMBUR 10-TEST UX 100T
• Type of Device: METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11088934
• MDR Text Key: 244804462
• Report Number: 1823260-2020-03418
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• PMA/PMN Number: K032437
• 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: 02/22/2021

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 Catalogue Number: 11544373191
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1