MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PLUS KIT USA; PROTHROMBIN TIME MONITOR

Catalog Number 04800842160

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The customer called stating the coaguchek xs plus meter (serial number (b)(4)) was powering off on its own during a test.During troubleshooting the call agent advised the customer to clean the battery contacts.The customer stated one of the contacts looks burnt.There was no adverse event.The meter was requested to be returned and a replacement meter was sent.

Manufacturer Narrative

The meter was evaluated and the investigation results showed that there were no burn marks on the battery contacts.One of the battery contacts was bent but it did not influence the functionality of the meter.The meter did not show any failure.

• Brand Name: COAGUCHEK XS PLUS KIT USA
• Type of Device: PROTHROMBIN TIME MONITOR
• 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: 5416808
• MDR Text Key: 38249839
• Report Number: 1823260-2016-00120
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04800842160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1