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 Consequences Or Impact To Patient (2199)

Event Date 11/20/2015

Event Type  malfunction  

Event Description

The customer reported they received false results from the urisys 1100 analyzer serial number (b)(4).The customer stated the issue has been occurring for several months and on several specimens.Specific data could not be provided.For "blood" (erythrocytes), the results would range from negative to "++".The result from the laboratory would then be positive.The test was repeated with the same results.For leukocytes, the results would range from negative to "++".There was no adverse event.A new vial of test strips was used with the same issue.The customer cleaned the tray of the analyzer, but the issue persisted.Controls were performed.Return of the meter and test strips were requested.Replacement meter and strips were sent.

Manufacturer Narrative

A specific root cause could not be identified.No customer material was received for investigation.Retention material was tested and the results met specifications.

• Brand Name: CHEMSTRIP ® 10 MD
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5261189
• MDR Text Key: 32510395
• Report Number: 1823260-2015-04662
• 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: Nursing Assistant
• Type of Report: Initial,Followup
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nursing Assistant
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 03260763160
• Device Lot Number: 20308601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2015
• 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