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

Catalog Number	05021537001
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The meter was requested for investigation.
Event or Problem Description
We received an allegation of an intermittent display issue on a coaguchek xs plus meter.The customer alleges that the meter will display an inr result for a few seconds after running a test and then the result will disappear and the meter returns to the main menu.The hourglass will then reappear on the display screen.None of the results from this issue were located in the meter memory.
Additional Manufacturer Narrative
The meter was received for investigation.Sections d9 and h3 were updated.Obvious signs of mechanical impact were visible on the meter's casing.The meter was disassembled for further investigation of the electronic parts.No abnormalities were observed with the electronic parts, however, contamination was identified.A broken heater ceramic and damage around where the test strip is inserted were identified.The observed damage is due to a strong impact or a fall.The investigation determined the issue was due to improper handling of the device by the customer.

• 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: 16333160
• Report Number: 1823260-2023-00413
• Device Sequence Number: 12341100
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2023

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
• 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: 01/12/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 03/21/2023
• 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