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

Model Number XS PST

Device Problems Circuit Failure (1089); Image Display Error/Artifact (1304)

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

Event Date 09/02/2022

Event Type  malfunction  

Manufacturer Narrative

Per product labeling for error 8: an error occurred during the internal diagnostic test.Turn the meter off and remove the batteries.Wait at least 1 minute before re-inserting the batteries into the battery compartment.Re-set the date and time as described in the meter setup section of this manual.Caution: the date and time must be set correctly.Repeat the test.If you see the same error message again, the meter has a defect.Call the roche customer support center at (b)(6).The meter was requested to be returned, but has not been received at this time.The investigation is ongoing.

Event Description

There was an allegation of a display issue with the coaguchek xs meter.While troubleshooting an error 8 from the meter, the customer mentioned that the display showed only part of an "8".A display check was performed and all segments were visible, but the display was flickering in and out.There was no allegation of a result misinterpretation.

Manufacturer Narrative

The customer's meter was received for investigation.The display did not flicker during the examination and all displays were complete and legible.The circuit board showed no contamination.The issue could not be reproduced or confirmed.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15488425
• MDR Text Key: 306262607
• Report Number: 1823260-2022-02941
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• 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: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• 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: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2022
• 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