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

Catalog Number 03260763160

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was requested for return, but was not provided.

Event Description

The customer complained of false positive nitrite results for 3 patient samples that were tested on a urisys 1100 urine analyzer with serial number (b)(4).Patient 1 initial nitrite result from the meter was positive.The doctor looked at the urine under a microscope and "did not see any nitrites".On (b)(6) 2018 patient 2 initial nitrite result from the meter was positive.The doctor sent out a urine culture out of the laboratory and the nitrite result was negative.On (b)(6) 2018 patient 3 initial nitrite result from the meter was positive.The doctor looked at the urine under a microscope and "did not see any nitrites".The microscopic observation and culture testing was performed using the same urine sample that was used for the strip measurement.The erroneous results were reported outside of the laboratory to a doctor.There was no treatment or medication provided to the patients.There was no allegation of an adverse event.The patients are in stable condition.The urine samples were not swirled and the urine was dropped onto the strip using a pipette.The testing was performed immediately after collecting the urine samples.The test strips were stored properly.Control testing was not recently performed on the meter.The analyzer and test strips were requested for investigation.Only the meter was returned for investigation.Retention material of lot #20318400 was measured on an iu urisys 1100 with native urine and a nitrite-dilution-series.The results fulfilled the requirements.No false positive results were observed.

Manufacturer Narrative

The urine samples were dropped onto the test strip using a pipette and according to product labeling the test strips are suppose to be dipped into the urine sample.Further investigation also noted that nitrites can not be observed using a microscope.Nitrite producing bacteria may be potentially seen under a microscope but not all bac types produce nitrites.

Manufacturer Narrative

Since qc testing was not performed with the meter, an instrument issue cannot be excluded.Further investigation could not be performed as the suspect product was not returned.

Manufacturer Narrative

The investigation was unable to find a definitive root cause.

• 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: 7308898
• MDR Text Key: 101701016
• Report Number: 1823260-2018-00623
• 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,Followup,Followup
• Report Date: 05/29/2018

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
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 03/02/2018
• Supplement Dates Manufacturer Received: 02/12/2018; 02/12/2018; 02/12/2018
• Supplement Dates FDA Received: 03/27/2018; 05/07/2018; 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1