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

Catalog Number	04837975001
Medical Device Problem Code	Display Difficult to Read (1181)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter had an issue with the meter display with a coaguchek xs meter.The reporter stated the result field of the meter was faded.A display check was attempted and the reporter was not able to get a full display on the screen.The reporter entered the meter memory and could see the last result of 2.2 inr but the result was faded.There was no misinterpretation of any results.
Additional Manufacturer Narrative
The meter was requested for investigation.
Additional Manufacturer Narrative
The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause could not be determined.

• Brand Name: COAGUCHEK XS PROF KIT
• Common Device Name: 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12861852
• Report Number: 1823260-2021-03451
• Device Sequence Number: 4232069
• Product Code: GJS
• UDI-Device Identifier: 00365702126107
• UDI-Public: 00365702126107
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 04837975001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown