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

Model Number XS PST

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The customer stated that she changed the batteries in the coaguchek xs meter serial number (b)(4) six months ago.The meter needed new batteries again, so she looked in the battery compartment.There was corrosion in the battery compartment.The customer removed the batteries and put in one new battery.Upon insertion of the battery, the meter sparked and she noticed burn marks in the battery compartment.She removed the one battery with a pen and left the batteries out of the meter.The customer did not know what type of batteries she had in the meter.The customer did not need any medical treatment and will not seek any medical treatment.No actions were taken based on the event and no adverse events were alleged to have occurred.The customer's meter was requested for investigation and a replacement meter was sent to the customer.

Manufacturer Narrative

The meter was returned for investigation.The meter could not be turned on since the battery contacts in the compartment were contaminated due to a battery that had leaked.The device was opened and no abnormalities were observed.The contamination and discoloration in the battery compartment were caused only by leakage of a battery.Marks of increased heat or evidence of fire were not visible.

• 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: 7156626
• MDR Text Key: 96450376
• Report Number: 1823260-2018-00012
• 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
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: XS PST
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2017
• 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