CHEMSTRIP MICRAL URINE TEST STRIPS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for CHEMSTRIP MICRAL URINE TEST STRIPS manufactured by Roche Diagnostics.

Event Text Entries

[143417023] 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.
Patient Sequence No: 1, Text Type: N, H10

[143417024] 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). The patient is male.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1823260-2019-90131
• MDR Report Key: 8549728
• Date Received: 2019-04-25
• Date Added to Maude: 2019-04-25
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MICHAEL LESLIE
• Manufacturer Street: 9115 HAGUE ROAD NA
• Manufacturer City: INDIANAPOLIS IN 46250
• Manufacturer Country: US
• Manufacturer Postal: 46250
• Manufacturer Phone: 3175214343
• Manufacturer G1: ROCHE DIAGNOSTICS GMBH
• Manufacturer Street: SANDHOFFERSTRASSE 116 NA
• Manufacturer City: MANNHEIM (BADEN-WURTTEMBERG), NA 68305
• Manufacturer Country: GM
• Manufacturer Postal Code: 68305
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: CHEMSTRIP MICRAL URINE TEST STRIPS
• Generic Name: URINARY PROTEIN OR ALBUMIN (NONQUANTITATIVE) TEST SYSTEM
• Product Code: JIR
• Date Received: 2019-04-25
• Model Number: MICRAL
• Lot Number: 33829802
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ROCHE DIAGNOSTICS
• Manufacturer Address: 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-04-25