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

Catalog Number 03260763160

Device Problem Low Test Results (2458)

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

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).The customer no longer has the vial of test strips.

Event Description

The customer complained of a "negative" result for 1 patient tested for blood on urisys 1100 urine analyzer serial number (b)(4).The date of event is an approximation.The event occurred approximately "2 weeks ago." the result from a urine sample when tested for blood on urisys 1100 urine analyzer serial number (b)(4) was "negative." the patient was tested on a different urisys 1100 analyzer with an unspecified serial number and the result for blood was "2 + +." there was no allegation that an adverse event occurred.The customer stated that qc had not been run on the meter.The meter and test strips were requested for investigation, however, the customer no longer has the test strips to return.

Manufacturer Narrative

The returned urisys 1100 analyzers (s/n ux09629940; ux09632917; ux09660982) were tested with retention strips.False negative results were produced with all customer devices and both claimed strip lots.These results indicate the concentrations are near the limit of detection.The investigation is ongoing.

Manufacturer Narrative

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.

• 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: 7490960
• MDR Text Key: 108157615
• Report Number: 1823260-2018-01404
• 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
• Report Date: 11/13/2018

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 Catalogue Number: 03260763160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 04/23/2018; 04/23/2018
• Supplement Dates FDA Received: 09/25/2018; 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1823260-09/12/18-006-C
• Patient Sequence Number: 1