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

Model Number XS PST

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The patient's wife called and stated that coaguchek xs meter would not power on.She changed the batteries in the meter using (b)(6) alkaline batteries.She then stated that the meter was getting very hot after changing the batteries.She then took the batteries out of the meter and noticed that the battery compartment of the meter was melted and black.The batteries were also melted.There were no adverse events.There was no smoke or flames detected.The meter has been requested for investigation and a new meter will be shipped to the customer.

Manufacturer Narrative

Investigations of the returned meter have determined that the issue was related to a handling issue as the battery compartment and contacts were found to be contaminated due to leaking batteries.The allegation that the meter was very hot could not be confirmed.The housing does not show any damage caused by heat.

• Brand Name: COAGUCHEK ® XS SYSTEM
• 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: 6169870
• MDR Text Key: 62382438
• Report Number: 1823260-2016-01948
• 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: 01/30/2017

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 Model Number: XS PST
• Device Catalogue Number: 04837738001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/30/2017
• 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