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

Catalog Number 03666794001

Device Problems Display Difficult to Read (1181); Device Difficult to Setup or Prepare (1487)

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

Event Date 09/22/2023

Event Type  malfunction  

Event Description

We received an allegation of a display issue on a coaguchek xs meter.During a display check for results in the meter memory, the customer alleged the display was faded.

Manufacturer Narrative

Section e3: occupation is patient/consumer.The meter was requested for investigation.The meter was received for investigation.The investigation is ongoing.

Manufacturer Narrative

The investigation of the returned meter found the battery contacts and the printed circuit board (pcb) were contaminated by liquid which penetrated/corroded the solder contacts.This affects the battery contacts on the circuit board causing the issue observed by the customer.The event was due to contamination of the contacts due to improper 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: 17966154
• MDR Text Key: 326055697
• Report Number: 1823260-2023-03352
• 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: 11/03/2023

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: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/19/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/03/2023
• 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