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

Catalog Number 03666794001

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 02/24/2020

Event Type  malfunction  

Manufacturer Narrative

The customer¿s meter was requested for return.The investigation is ongoing.

Event Description

The initial reporter complained of a burning or charring issue with coaguchek xs meter serial number (b)(4).The customer complained of various error messages (example: error 4) and was unable to perform a test.It was noted that the heater plate appeared to be charred or burnt.There were no other signs of burning, melting, or smoking to any other portion of the meter.

Manufacturer Narrative

The customer's meter was received for investigation.The meter¿s circuit board was tested for damage or contamination and it was found the test strip area (tsa) was badly damaged by a fall.As a result, the capacitor c248 was torn off, the test strip contacts were badly damaged and the heating ceramic was broken (handling error).The heating ceramic shows no signs of burning.The root cause is determined to be damage due to improper handling or maintenance by the customer.

• 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: 9860755
• MDR Text Key: 184302851
• Report Number: 1823260-2020-00793
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2020
• 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