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

Catalog Number 03260763160

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

The customer received questionable results for 4-8 patient samples while using the urisys 1000 urine analyzer (serial number (b)(4)).The customer stated they were seeing differences between the meter and the laboratory results when testing the patients' urine.Of the data provided, it was noted that there was one patient whose result was erroneous.This patient's urine tested negative for blood on the meter but showed as 2+ for blood in the laboratory.It was stated that no treatment was received as a result of the test.Information concerning when the correct controls were last run, which result they believed to be correct, if any results were reported outside of the laboratory and which analyzer was used was requested, but it was not provided.It was stated that the strips have been stored correctly.The calibration had been run last on the urisys 1100 urine analyzer on (b)(6) 2016.They were not using the recommended controls on the meter.There was no adverse event reported.The suspect product was requested to be returned and the replacement product was sent.The retention material of lot 205 266 00 was measured with 0-artificial urine, 0-native and a blood- dilution series.There were no false results that were observed.

Manufacturer Narrative

A specific root cause for the event could not be determined.The customer returned the meter but not the strips.No visible defects were seen.The customer's meter was tested along with a retention meter using strips from retention lot 205 266 00.They were measured with 0-native urine and a blood- dilution series.There were no false negatives observed.The measurements between the two devices were comparable.All measurements were within requirements.The strips were not returned for investigation.

• Brand Name: CHEMSTRIP ® 10 MD
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5808961
• MDR Text Key: 50000530
• Report Number: 1823260-2016-00933
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 03260763160
• Device Lot Number: 20526602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1