MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHEMSTRIP ® 10 MD; URINE TEST STRIPS

Catalog Number 03260763160

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2018

Event Type  malfunction  

Event Description

The customer complained of a false negative erythrocyte result for 1 patient urine sample that was tested on a urisys 1100 urine analyzer with serial number (b)(4) and compared to an unknown laboratory method.The initial erythrocyte result from the urisys was negative.The sample was sent to another hospital and a result of 3 or 4 plus.The customer could not remember the exact time between the measurements but did state that they were done between 6-24 hours of each other.The erroneous result was released outside of the laboratory.There was no allegation of an adverse event.Qc testing was performed with acceptable results.The meter and test strips have been requested for investigation.The retention material of the lot 32223100 was measured on an iu u 1800 analyzer with 0-native urine, and an erythrocytes-dilution-series.No false negative results were observed.The investigation is currently ongoing.

Manufacturer Narrative

The customer's meter was returned.The test strip tray was inserted too deep into the analyzer.During self-check, an error message "e10 light barrier error" was produced.As the tray did not move out of the analyzer, no measurements could be made on the customer's analyzer.The test strips were not returned.

Manufacturer Narrative

No further investigation is possible since the customer did not return the requested product for testing.

• Brand Name: CHEMSTRIP ® 10 MD
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8060594
• MDR Text Key: 128481087
• Report Number: 1823260-2018-04199
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 00075537313121
• UDI-Public: 00075537313121
• Combination Product (y/n): N
• PMA/PMN Number: K032437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2019

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 Expiration Date: 07/31/2019
• Device Catalogue Number: 03260763160
• Device Lot Number: 32223101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2018
• Initial Date FDA Received: 11/12/2018
• Supplement Dates Manufacturer Received: 10/24/2018; 10/24/2018
• Supplement Dates FDA Received: 01/25/2019; 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1