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

Catalog Number 03260763160

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer questioned urobilinogen and erythrocytes results on urisys 1100 urine analyzer serial number (b)(4).Based on the data provided, 1 patient had erroneous erythrocytes results.The initial erythrocyte result from the analyzer was negative.While the customer was waiting for the result from the analyzer, the customer read the strip visually and the result was 1+ (50 cells/microliter).The patient did not receive any treatment.No adverse event occurred.The patient is in "excellent" condition.The analyzer and test strips were requested for investigation.

Manufacturer Narrative

The retention material lot # 20318400 was measured on a urisys 1100 at the investigation site and visually checked with 0-native urine and a erythrocyte-dilution-series according to the testing plan.The results of the measurements were acceptable.No false negative results were observed.

Manufacturer Narrative

A specific root cause was not identified.Additional information was requested for investigation but was not provided.The customer has not returned any product.

• 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: 7049880
• MDR Text Key: 93311907
• Report Number: 1823260-2017-02711
• 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,Followup
• Report Date: 01/12/2018

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: 04/30/2018
• Device Catalogue Number: 03260763160
• Device Lot Number: 20318404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 11/07/2017; 11/07/2017
• Supplement Dates FDA Received: 12/27/2017; 01/12/2018
• 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
• Patient Age: 64 YR
• Patient Weight: 84