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

Catalog Number 03260763160

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

The reporter's product has been requested for investigation and replacement product was sent to the reporter.

Event Description

The initial reporter stated they have received questionable test results for an unspecified number of patient samples tested using multiple chemstrip 10 md test strip lot numbers with multiple urisys 1100 analyzers.The results measured using the analyzers did not match results obtained with a visual reading of the test strips.The issues occurred after installing a new software version ((b)(6)) on each urisys 1100 analyzer.The reporter provided data for a total of 60 patient samples and of these, 9 had discrepant test results when tested with the following devices: urisys 1100 analyzer serial number (b)(4) used with test strip lot number 38055401 (expiration date = 30-apr-2020).Urisys 1100 analyzer serial number (b)(4) used with test strip lot number 36255001 (expiration date = 31-jan-2020).Urisys 1100 analyzer serial number (b)(4) used with test strip lot number 36897002 (expiration date = 29-feb-2020).Urisys 1100 analyzer serial number (b)(4) used with test strip lot number 38055405 (expiration date = 30-apr-2020).Urisys 1100 analyzer serial number (b)(4) used with test strip lot number 34762802 (expiration date = 30-nov-2019).The affected tests include nitrite and erythrocytes.

Manufacturer Narrative

The retention material of test strip lot 347628 was measured on a retention cobas u411 / urisys 1800 and was checked by visual reading with native urine and a erythrocytes dilution series.The retention material of test strip lots lot 362550 and 380554 were measured on a retention cobas u411 / urisys 1800 and were checked by visual reading with native urine, a erythrocytes dilution series and a nitrite dilution series.The retention material of lot 368970 was measured on a retention cobas u411 / urisys 1800 and was checked by visual reading with native urine and a nitrite dilution series.The retention material showed no false positive or negative results and fulfilled requirements.

• 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: 9349376
• MDR Text Key: 219613720
• Report Number: 1823260-2019-04138
• 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: 05/05/2020

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: 11/30/2019
• Device Catalogue Number: 03260763160
• Device Lot Number: 34762802
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 10/31/2019
• Supplement Dates FDA Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1