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

Catalog Number 03260763160

Device Problem Low Test Results (2458)

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

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received questionable results for one patient sample from urisys 1100 serial number (b)(4).The urine results were negative for leukocytes, protein, and nitrites.A visual test was performed minutes later on the sample and the results were: leukocytes: positive; protein: trace ; nitrite: positive.On (b)(6) 2017, the sample was tested in the laboratory by an unknown analyzer and the results were: leukocytes: "+++" ; protein: positive; nitrite: negative.Clarification of the specific results was requested, but was not provided.The erroneous results were reported outside of the laboratory.Treatment was provided to the patient based on laboratory results.There was no allegation of an adverse event.The customer stated the issue first began three weeks ago, but they had determined the strips were being handled incorrectly, as they were kept uncapped for prolonged periods of time.The qc performed on the day of the event passed.The suspect device and strips were requested to be returned for further investigation.

Manufacturer Narrative

As no material was received form the customer, further investigation was not possible.The retention material of lot #18697700 was measured on an iu urisys 1100 with 0-native urine and a leucocyte-dilution-series, a protein-dilution-series and a nitrite-dillution-series and was visually checked.The results of the measurements fulfill the requirements.No false negative results were observed.

• 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: 7032946
• MDR Text Key: 93115299
• Report Number: 1823260-2017-02617
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 03260763160
• Device Lot Number: 18697701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2017
• 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