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

Model Number XS PST

Device Problem Image Display Error/Artifact (1304)

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

Event Date 07/25/2022

Event Type  malfunction  

Manufacturer Narrative

Occupation is patient/consumer.The customer did not see any corrosion in the battery compartment.The meter was requested for investigation.

Event Description

We received an allegation of a display issue with a coaguchek xs meter.The customer alleged the meter displayed code 8.There was no "error" icon with the number 8.After a few moments, the meter displayed code 48 while the strip was inserted.After a few more moments the meter displayed code 481.The issue is affecting the results field of the display.Upon completion of a display check, the display was complete.

Manufacturer Narrative

The customer's meter was returned for investigation.Observed that the returned meter powered on with fresh retention batteries.A full display check was performed and revealed no missing or faded segments.No display issues were observed.The battery compartment was examined and revealed no signs of damage or contamination.The customer's allegation could not be reproduced.The returned meter performed according to specifications.

• 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: 15260541
• MDR Text Key: 305178537
• Report Number: 1823260-2022-02503
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• 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: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• 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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1