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

Catalog Number 03666794001

Device Problems Display Difficult to Read (1181); Image Display Error/Artifact (1304)

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

Event Date 09/05/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

We received an allegation of a display issue with coaguchek xs meter serial number (b)(6).The customer stated the meter display is faint and difficult to read.There was no misinterpretation of results.

Manufacturer Narrative

The meter was returned for investigation.The returned meter did not power on.The meter was optically inspected and contamination from fluid ingress was observed on the printed circuit board.The contamination caused a power interruption which prevents the meter from powering on.Additionally, the contamination can cause faded/missing segments.The cause of the issue is contamination due to 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17817240
• MDR Text Key: 324249396
• Report Number: 1823260-2023-03102
• 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: 10/12/2023

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
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 10/04/2023
• Supplement Dates FDA Received: 10/12/2023
• 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