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

Catalog Number 03260763160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

The urisys analyzer was calibrated within the last 7 days and qc results on the date of the event were acceptable.The investigation is currently ongoing.The event occurred in: (b)(6).

Event Description

The initial reporter complained of high leukocyte and nitrate results for 1 patient tested on a urisys 1100 urine analyzer serial number (b)(4) compared to an arkray instrument.From the urisys the leukocytes showed a result of 500 and positive for nitrates.From the arkray instrument, both the leukocytes and nitrate results were negative.The results in question were reported outside of the laboratory.

Manufacturer Narrative

Medwatch field d4.Has been updated.

Manufacturer Narrative

The customer's analyzer ((b)(6)) was returned with a test strip tray.The test strips were not returned.The analyzer was clean and showed no damage.The customer's analyzer was measured with another strip lot (43065200) with 0-native urine.The customer material showed no false positive results and fulfill the requirements.The investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

The retention material of lot 38055400 was measured using retention analyzers and was checked by visual reading with 0-native-urine, a erythrocytes-dilution-series and a nitrite-dilution-series.The retention material showed no false positive or negative results and fulfill the requirements.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 9254662
• MDR Text Key: 219372859
• Report Number: 1823260-2019-03890
• 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: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 03260763160
• Device Lot Number: 38055405
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN; ATORVAFTATIN; CLOPIDOGREL; MULTIVITAMIN; NITROGLYCERIN
• Patient Age: 68 YR