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

Catalog Number 11544373191

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter complained of false positive results for an unspecified number of patients tested for nitrite on urisys 1100 analyzer with serial number (b)(4).The nitrite results were positive from the urisys analyzer.The nitrite results were negative when testing on a cobas u 601 analyzer.The positive results were reported outside of the laboratory.The customer also had qc issues with the leukocyte parameter.The customer stated the test strips were not discolored prior to use.There was no allegation that an adverse event occurred.The meter and test strips were requested for investigation.

Manufacturer Narrative

The customer returned the instrument and test strips.The test strips and accompanying strip vial did not show any abnormalities.The instrument was clean and no damage was observed.The customer's test strips and retention strips with the same lot number were tested on a urisys analyzer and a u 411 instrument at the investigation site along with the customer's returned instrument.The results of the measurements of the customer material and the retention material fulfill the requirements.No false positive or abnormal results were observed.The investigation did 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: 8469856
• MDR Text Key: 140512149
• Report Number: 1823260-2019-01273
• 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: 05/06/2019

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: 35703303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/01/2019
• Supplement Dates Manufacturer Received: 03/13/2019
• Supplement Dates FDA Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1