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

Catalog Number 03666794001

Device Problems Display Difficult to Read (1181); No Display/Image (1183); Activation Problem (4042)

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

Event Date 09/25/2023

Event Type  malfunction  

Manufacturer Narrative

On the call, a display check couldn't be done on the meter due to loss of power.The meter was provided for investigation.The investigation is ongoing.

Event Description

We received an allegation about a display issue on a coaguchek xs meter.The patient alleged that the meter turned on with a faded display too faint to read then it turned off.He replaced the batteries with new ones.The patient wasn't able to run a test as the meter did not power back on.

Manufacturer Narrative

The device code (a code) was updated.The patient's device was provided for investigation.The device could not be turned on.The device data and the fault memory could not be read out.The circuit board was tested for damage or contamination.The battery contacts and the printed circuit board were contaminated by the liquid from the leaked battery which had penetrated and corroded the solder contacts.The root cause was contamination of the contacts due to improper handling or maintenance.The investigation did not identify a product problem.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17976556
• MDR Text Key: 326165927
• Report Number: 1823260-2023-03372
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (y/n): Y
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• 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: 10/17/2023
• Date Manufacturer Received: 11/02/2023
• 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
• Patient Sex: Male