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 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated that they received erroneous results for two patients tested with chemstrip 10 md urine test strips on urisys 1000 urine analyzer serial number (b)(6).The customer is not sure of the date of the event and stated that the event most likely occurred one week prior to (b)(6) 2017.The patients had negative or trace leukocyte results when tested using the test strips and urisys 1100 analyzer.The doctor looked at the patient urine samples under a microscope and there were so many leukocytes in the urine, the samples appeared to be "2+".No adverse events were alleged to have occurred with the patients.The meter was not exposed to direct sunlight.The customer is not sure if the urine samples were swirled prior to testing.Quality controls were tested and these were within range.

Manufacturer Narrative

The customer's product was not returned for investigation, so no further investigation was possible.Retention material of test strip lot 152299 was measured on a retention meter using native urine and a leukocyte dilution series.The test strips were visually checked.The results of the measurements fulfilled requirements and no false negative results were observed.No further customer complaints have been received for test strip lot 152299.The customer was using expired test strips.It is highly recommended to not use expired test strips.

• 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: 6979057
• MDR Text Key: 91095970
• Report Number: 1823260-2017-02421
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

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: 09/30/2017
• Device Catalogue Number: 03260763160
• Device Lot Number: 15229901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 10/26/2017
• Supplement Dates Manufacturer Received: 10/10/2017
• Supplement Dates FDA Received: 11/21/2017
• 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