MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR 10 UX 100; URINE TEST STRIPS

Catalog Number 11544373049

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that they received discrepant results for one patient sample tested for nitrites using combur 10 ux test strips on urisys 1100 analyzer serial number (b)(4).The sample initially resulted with a positive nitrite result.The sample was repeated three times, each time resulting with a negative nitrite result.No adverse events were alleged to have occurred with the patient.

Manufacturer Narrative

The customer¿s meter and strips were requested for investigation, but the customer could not provide them.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COMBUR 10 UX 100
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8779987
• MDR Text Key: 150762149
• Report Number: 1823260-2019-02513
• 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: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11544373049
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1