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

Catalog Number 04625412003

Device Problem Image Display Error/Artifact (1304)

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

Event Date 07/23/2023

Event Type  malfunction  

Manufacturer Narrative

Section e3: occupation is patient/consumer.The customer replaced the batteries.There was no indication of leaking batteries.The meter was requested for investigation.

Event Description

There was an allegation of a display issue with a coaguchek xs meter.The date of event is an approximation.The reporter stated the issue occurred in "the last weeks." the customer alleged the display was becoming weaker and weaker and that there were "some" segments missing from the results field.

Manufacturer Narrative

Sections d9 and h3 were updated.The meter was received for investigation.The device could not be turned on.It was found that the battery contacts and the printed circuit board (pcb) were contaminated by penetrated liquid which penetrated/corroded the solder contacts.This affects the battery contacts and the conductive rubber contacts on the circuit board and caused the issue observed by the customer.The investigation determined the event was due to contamination of the contacts due to improper customer handling or maintenance.

• 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: 17565182
• MDR Text Key: 321381426
• Report Number: 1823260-2023-02677
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

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 Catalogue Number: 04625412003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 09/28/2023
• 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