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

Catalog Number	03260763160
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem 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.
Additional 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.
Additional 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.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: CHEMSTRIP ® 10 MD
• Common Device Name: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8023107
• Report Number: 1823260-2018-03938
• Device Sequence Number: 19177573
• Product Code: JIL
• UDI-Device Identifier: 00075537313121
• UDI-Public: 00075537313121
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 03260763160
• Device Lot Number: 32223101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 10/10/2018; 10/10/2018; 10/10/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 11/29/2018; 01/28/2019; 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1