MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHEMSTRIP ® 10 UA; METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)

Catalog Number 11895354160

Device Problem Low Test Results (2458)

Patient Problems Urinary Tract Infection (2120); Urinary Frequency (2275)

Event Date 02/11/2019

Event Type  malfunction  

Event Description

The initial reporter complained of false negative results for 1 patient using chemstrip 10 ua test strips on a urisys 1100 urine analyzer.The patient had been in the hospital previously and had a catheter.The patient had been discharged but returned with urination urgency issues.The patient tested negative for all parameters of the test strip.The customer sent out a confirmation culture.The confirmation culture results were around 100,000 cfu.Leukocytes were 5000.The customer believed the patient had some sort of infection.The patient's urine was sent for another culture on (b)(6) 2019.The urinalysis returned as positive for leukocytes and erythrocytes and the nitrites were negative.The customer received the final report on (b)(6) 2019 and the report indicated e-coli was growing (100,000 cfu-ml).After the final report was received, the patient was diagnosed with a urinary tract infection.Treatment for the infection was delayed between (b)(6) 2019.The specific treatment provided is not known.An adverse event did not occur due to delaying the treatment by 2 days.The meter and test strips were requested for investigation.

Manufacturer Narrative

Retention material for strip lot 33828901 was measured with 0-native-urine and a nitrite-dilution-series and visually checked.The results of the measurements for all retention and customer materials fulfill our requirements.No false negative results were observed.

Manufacturer Narrative

The customer meter was requested but not returned.One vial of lot 29191102 "chemstrip 10 ua 100 str.", containing 87 of 100 test strips was returned.During internal testing, roche determined the limits of detection (lod) for protein, nitrite, leukocytes, and erythrocytes on the urisys 1100 urine analyzer with chemstrip® 5 ob, chemstrip 7, chemstrip 10 md, and chemstrip 10 ua test strips were higher than what is listed in their respective test strip method sheets.This can lead to false negative results on the urysis 1100 urine analyzer for the four affected parameters.Roche has provided customers with the following instructions and workarounds: chemstrip 5 ob and chemstrip 7 test strips should only be read visually.They can no longer be read on the urisys 1100 urine analyzer.Chemstrip 10 md or chemstrip 10 ua test strips can be used with the urisys 1100 urine analyzer; however, a negative result for any one of the four affected parameters (i.E., protein, nitrite, leukocytes, and erythrocytes) on the urisys 1100 urine analyzer must be repeated with a new test strip that is read visually.

Manufacturer Narrative

The customer returned the meter (serial number (b)(6)).The limits of detection (lod) issue has since been resolved with a meter software version update.

• Brand Name: CHEMSTRIP ® 10 UA
• Type of Device: METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
• 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: 8461391
• MDR Text Key: 140612309
• Report Number: 1823260-2019-01237
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K896454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• 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: 11895354160
• Device Lot Number: 33828901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2021
• 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: A
• Removal/Correction Number: 1823260-09/12/18-006-C
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female