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

Catalog Number 03260763160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2019

Event Type  malfunction  

Manufacturer Narrative

The customer does not run qc.The customer used 3 vials of test strips with the same lot number.Two vials have been discarded.The one remaining vial was requested for investigation.

Event Description

The initial reporter complained of false positive nitrite results for 5 patients tested with chemstrip 10 md urine strips on urisys 1100 analyzer serial number (b)(4) on (b)(6) 2019 and (b)(6) 2019.When the meter result was "positive" for all 5 patients, all 5 patients were given antibiotics.No specific results were provided.A visual reading was not performed.The samples were sent to the laboratory and cultured.Two days after the meter results, the culture returned as negative for nitrites for all 5 patients.When the negative results were returned, the antibiotics were stopped.The physician stated none of the patients were adversely affected due to the antibiotics.No adverse event occurred.

Manufacturer Narrative

Investigation did retention testing on another lot 33828900 and on the customer lot.No false positive results were observed with meter or strips.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: CHEMSTRIP ® 10 MD
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8780585
• MDR Text Key: 150761933
• Report Number: 1823260-2019-02534
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• PMA/PMN Number: K032437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 03260763160
• Device Lot Number: 33828902
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1