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

Catalog Number 11544373049

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer intermittently received questionable false positive nitrite results for an unknown number of urine samples from an urisys 1100 analyzer.The serial number was requested but was not provided.Information concerning if any erroneous result was reported outside of the laboratory was requested but it was unknown.There was no allegation of an adverse event.The customer changed the strip tray, but the issue persisted.The customer then changed the vial strips in use and the issue was resolved.The suspect meter and strips were requested to be returned for investigation.

Manufacturer Narrative

The customer returned one vial of test strips vial lot 29189701 which showed no abnormalities.The return urisys 1100 analyzer (serial number (b)(4)) showed no damage.Retention material of lot #29189700 and the customer material were both measured on a retention urisys 1100 and on the customer's analyzer with native urine and a nitrite dilution series.The results of the testing fulfilled the requirements.No false positive results were observed.During testing, the test strip downholder on the customer device did not close correctly because of the heavy contamination.No further complaints have been received for this lot of test strips.

Manufacturer Narrative

The strip tray of the analyzer was contaminated.The investigation is ongoing.

• 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: 7723850
• MDR Text Key: 115577453
• Report Number: 1823260-2018-02272
• 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,Followup,Followup
• Report Date: 09/19/2018

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 Expiration Date: 04/30/2019
• Device Catalogue Number: 11544373049
• Device Lot Number: 29189701
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/27/2018
• Initial Date FDA Received: 07/26/2018
• Supplement Dates Manufacturer Received: 06/27/2018; 06/27/2018; 06/27/2018
• Supplement Dates FDA Received: 08/09/2018; 08/28/2018; 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1