MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHEMSTRIP ® 10 UA; METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)

Catalog Number 11895354160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

The reporter's test strips were requested for investigation.The retention material of chemstrip 10 ua lot 390097 was measured on a retention cobas u411 with native urine and a nitrite dilution series.The measurements showed no false positive results and showed no abnormalities.(b)(6).

Event Description

The initial reporter stated that on 18-sep-2019 and 19-sep-2019, the received discrepant results for a total of 25 patient samples tested for nitrites using chemstrip 10 ua test strips with cobas u 411 analyzer serial number (b)(4).All 25 samples initially resulted with positive nitrite values when tested on the u 411 analyzer.These initial positive results were reported outside of the laboratory and questioned by a doctor.The samples were repeated on the same u 411 or a second u 411 analyzer and all repeat nitrite results were negative.Corrected reports were issued for the repeat values.All patient data and demographics are provided in the attachment.The affected samples are labeled samples 1 through 25.The last 3 pages (pages 52 - 54) represent data from unknown patient samples.It was asked, but it is not known if this data is from one of the 25 affected patient samples or if the data is from other patient samples.These samples are labeled as unknown samples 1 through 6.Data on the left side of these pages represent data from the complained u 411 analyzer.Data on the right side of these pages represent data from a second u 411 analyzer.

Manufacturer Narrative

No customer material was returned.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: CHEMSTRIP ® 10 UA
• Type of Device: METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9178511
• MDR Text Key: 209806551
• Report Number: 1823260-2019-03648
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• PMA/PMN Number: K896454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 11895354160
• Device Lot Number: 39009702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR