MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME MONITOR

Catalog Number 03666794689

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2015

Event Type  malfunction  

Event Description

Caller advised that two of the batteries on the coaguchek xs system had corrosion, and that the battery cover looked like it was melted.The batteries and the battery cover did not feel warm to the touch.Requested return of suspect system and replacement was sent.

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4609260
• MDR Text Key: 5632123
• Report Number: 1823260-2015-02061
• 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: Consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 03/25/2015

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
• Device Operator: Patient Family Member or Friend
• Device Catalogue Number: 03666794689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2015
• Initial Date FDA Received: 03/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1