MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHEMSTRIP MICRAL URINE TEST STRIPS; URINARY PROTEIN OR ALBUMIN (NONQUANTITATIVE) TEST SYSTEM

Model Number	MICRAL
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's product was returned for investigation.The test strips did not show any abnormalities.The customer material and relevant retention material were tested with five different human serum albumin solutions and the results from the investigation were in accordance with the testing plan.No product failure was detected.There were no follow up/corrective actions for this event.The device was returned.This device is not labeled for single use and is not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction event.Low results were generated by the chemstrip micral.The event involved a total of 1 patient.The patient's age is (b)(6) years.The patient is male.

• Brand Name: CHEMSTRIP MICRAL URINE TEST STRIPS
• Common Device Name: URINARY PROTEIN OR ALBUMIN (NONQUANTITATIVE) TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8549728
• Report Number: 1823260-2019-90131
• Device Sequence Number: 2309112
• Product Code: JIR
• UDI-Device Identifier: 00075537171462
• UDI-Public: 00075537171462
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: No Information
• Device Model Number: MICRAL
• Device Lot Number: 33829802
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2019
• Patient Sequence Number: 1