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

Catalog Number	05021537001
Medical Device Problem Codes	Image Display Error/Artifact (1304); Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The meter has been requested for investigation.The meter has not been received at this time.If the meter is returned in the future, a follow-up report will be submitted.
Event or Problem Description
We received an allegation about a dark screen on a coaguchek xs plus meter.It was reported that the meter screen is too dark to clearly read or interpret the results.The screen contrast was increased from 8 to 10 but is still too dark to read.When the meter is placed into the base unit, the results are still uploaded to the dms system.No results have been misinterpreted due to the dark screen.
Additional Manufacturer Narrative
Fields d9 and h3 were updated.The meter was provided for investigation.The investigation found that the meter display has the same contrast and sharpness as a comparison device.The results are displayed normally and misinterpretation is not possible.There are no traces of an obvious mechanical impact visible on the housing of the device.The device was disassembled for further investigations of the electronic parts.The visual inspection of the electronic parts showed no abnormalities and no contamination was found.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COAGUCHEK XS PLUS
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15609070
• Report Number: 1823260-2022-03184
• Device Sequence Number: 2810078
• Product Code: GJS
• UDI-Device Identifier: 00365702164109
• UDI-Public: 00365702164109
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 12/22/2022

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: 05021537001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 12/22/2022
• 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