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 10/10/2018

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The customer complained of questionable results for 1 patient urine sample tested with chemstrip 10 md urine test strips on a urisys 1100 urine analyzer serial number (b)(4).Of the data provided, there were discrepant leukocytes, protein, erythrocyte, and glucose results.The initial leukocytes result was 75 leu/ul and the repeat result was 500 leu/ul.The initial protein result was trace and the repeat result was 500 mg/dl.The initial erythrocyte result was negative and the repeat result was 250 ery/ul.The initial glucose result was 50 mg/dl and the repeat result was negative.There were erroneous results reported outside of the laboratory.There was no allegation of an adverse event.The customer stated that the strip test pads visually appeared the same color.The calibration and qc were acceptable.The suspect product was requested to be returned for investigation.

Manufacturer Narrative

The retention material of lot 32223100 was checked visual with native urine, a specific gravity dilution series, a protein dilution series, a glucose dilution series, a leucocytes dilution series and an erythrocytes dilution series.No false negative results were observed and no false positive results for glucose were observed.

Manufacturer Narrative

The customer returned the affected meter for investigation.The meter was clean and showed no damage.Calibration was performed with retention materials, without any problems or errors.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 8023107
• MDR Text Key: 126555360
• Report Number: 1823260-2018-03938
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 00075537313121
• UDI-Public: 00075537313121
• 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: 02/06/2020

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: 07/31/2019
• Device Catalogue Number: 03260763160
• Device Lot Number: 32223101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 10/31/2018
• Supplement Dates Manufacturer Received: 10/10/2018; 10/10/2018; 10/10/2018
• Supplement Dates FDA Received: 11/29/2018; 01/28/2019; 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1