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

Model Number XS PST

Device Problems Circuit Failure (1089); Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2022

Event Type  malfunction  

Manufacturer Narrative

Occupation is patient/consumer.The meter was requested for investigation.

Event Description

The initial reporter complained of a battery issue with coaguchek xs meter serial number (b)(4).Customer stated two batteries in the meter are melted together.The meter was hot after the battery compartment was opened.No injuries occurred as a result of the melted batteries and hot meter.

Manufacturer Narrative

The meter was returned for investigation.The display of the device is completely destroyed, so the device is inoperable.The display shows damage due to strong heat exposure (e.G.Electromagnetic radiation of a microwave).This radiation also destroys electronic components on the mainboard preventing the meter from downloading memory.The batteries were not returned with the device.Based on the user's description, it can be assumed that the batteries were in the device when it was heated up from the outside by the microwave.The heating of the batteries then caused the plastic casing of the batteries to stick together.The cause of the issue was determined to be user error.

• 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: 13478746
• MDR Text Key: 292036406
• Report Number: 1823260-2022-00316
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• 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
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

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: Lay User/Patient
• Device Model Number: XS PST
• Device Catalogue Number: 04837738001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 03/08/2022
• Supplement Dates FDA Received: 03/24/2022
• 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
• Patient Sequence Number: 1