MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHEMSTRIP 7 100 STR.; URINE TEST STRIPS

Catalog Number 11008552119

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

This event occurred in (b)(6).Expiration date was provided as april 2018.

Event Description

The customer stated that they have an issue with 2 boxes of chemstrip 7 test strips.The customer stated that an unspecified number of patient samples had false negative erythrocyte results.When urine samples from the patients were tested with a different laboratory method, erythrocytes were detected.The negative values were reported outside of the laboratory.It was asked, but it is not known if the customer was performing a visual reading of the test strips or if the test strips were measured using a meter.No adverse events were alleged to have occurred with the affected patients.The customer's product was requested for investigation.

Manufacturer Narrative

No product was returned for investigation, so no further investigation was possible.A user handling issue could not be excluded.

Manufacturer Narrative

The retention material of test strip lot #21026701 was measured on a retention urisys 1100 analyzer with test samples.The results of the measurements fulfill requirements.No false negative results were observed.

• Brand Name: CHEMSTRIP 7 100 STR.
• 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: 6957762
• MDR Text Key: 90651635
• Report Number: 1823260-2017-02359
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K032437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2017

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 Catalogue Number: 11008552119
• Device Lot Number: 210267-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 10/18/2017
• Supplement Dates Manufacturer Received: 10/04/2017; 10/04/2017
• Supplement Dates FDA Received: 11/02/2017; 11/20/2017
• 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