COMBUR-10-M 100 STR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-06-19 for COMBUR-10-M 100 STR manufactured by Roche Diagnostics.

MAUDE Entry Details

• Report Number: 1823260-2019-02243
• MDR Report Key: 8711688
• Report Source: FOREIGN,HEALTH PROFESSIONAL,U
• Date Received: 2019-06-19
• Date of Report: 2019-09-10
• Date of Event: 2019-05-29
• Date Mfgr Received: 2019-05-29
• Date Added to Maude: 2019-06-19
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: NA 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: SANDHOFERSTRASSE 116 NA
• Manufacturer City: MANNHEIM (BADEN-WURTTEMBERG) 68305
• Manufacturer Country: GM
• Manufacturer Postal Code: 68305
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: COMBUR-10-M 100 STR
• Generic Name: URINE TEST STRIPS
• Product Code: JMT
• Date Received: 2019-06-19
• Model Number: COMBUR-10-M
• Catalog Number: ASKU
• Lot Number: 37378004
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ROCHE DIAGNOSTICS
• Manufacturer Address: 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-06-19