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 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received false positive nitrate results for three patient samples and a false positive leukocyte result for two of the patient urine samples.Of the data provided, only the results for nitrate were discrepant.Information was provided that one sample was sent to the laboratory for repeat resting and the result was negative.The laboratory results were considered to be correct.There was no allegation of an adverse event.The customer used urisys 1100 analyzer serial number (b)(4).

Manufacturer Narrative

Additional information was received that the laboratory analyzer used was clinitek 500.

Manufacturer Narrative

Retention material of lot #18697700 was measured on a (b)(4) with a native urine sample, a nitrite- sample, and a leucocyte- dilution series and was visually checked according to the testing plan.The results fulfilled the requirements.No false negative or false positive results were observed.

Manufacturer Narrative

One test strip container with 44 out of 100 test strips was received for investigation.The test strips showed a light dusty shade.The urisys 1100 analyzer was also received but was missing the test strip tray.The analyzer showed no signs of damage.Retention material of lot #18697700 and the customer material of lot #186 977 01 was tested on a retention urisys1100 analyzer and on the customer's analyzer urisys 1100 native urine, a nitrite- and a leucocyte-dilution-series.The results of the retention material measurements fulfill the requirements.No false negative or false positive results were observed.The results of the customer material measurements did not fulfill the requirements.False positive results for nitrate and leukocyte were received.The customer analyzer worked properly.The investigation was unable to find a definitive root cause.It appeared the customer strips had not been properly stored (tube not closed properly) and therefore the strips generate higher (false positive) results in comparison to retention material.

• 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: 7078958
• MDR Text Key: 94850998
• Report Number: 1823260-2017-02820
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 03260763160
• Device Lot Number: 18697701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2017
• 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