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

Catalog Number	03260763160
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The qcs meet acceptance criteria.There have been no further issues reported.The test strips were requested for investigation.No material was received.The retention material measurements fulfill the requirements and meet all specifications.No false-negative leukocyte results were obtained.The event is consistent with a sample that is not stored correctly or measured within two hours, due to cell lyse falsifying the microscopy results.The investigation did not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
There was a complaint of a questionable leukocyte result for 1 patient tested with a urisys 1100 urine analyzer serial number (b)(4).The questionable result was not reported outside the laboratory.The patient¿s initial meter result was negative.The customer looked at the sample under the microscope and saw approximately 20 - 30 white cells.The customer reran the same sample, same strip vial on the meter, and got a result of 2+ or 500 leu/ul.The timing between tests was within 15 minutes.The sample type was urine.

• Brand Name: CHEMSTRIP ® 10 MD
• Common Device Name: URINE TEST STRIPS
• 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: 12860228
• Report Number: 1823260-2021-03450
• Device Sequence Number: 17279696
• Product Code: LJX
• 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 Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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: 07/31/2022
• Device Catalogue Number: 03260763160
• Device Lot Number: 54510809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown