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

Catalog Number	04837975001
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation ni equals lay user/patient.
Event or Problem Description
The customer complained of an issue with their coaguchek xs meter serial number (b)(4) that may impact the interpretation of their results.The customer initially stated that their meter display appeared faded out.The customer changed the batteries but the issue remained.The customer performed a display check and stated the display was not complete and there were segments missing.The customer stated that the meter has not been used for testing since the display started to look different.There was no allegation of erroneous results or an adverse event.There was no information provided to reasonably suggest that there was any actual misinterpretation of results.The meter was requested to be returned for investigation.
Additional Manufacturer Narrative
The customer's meter was received for investigation.The display shows no error.The meter¿s circuit board was tested for contamination and it was found the circuit board was contaminated.The root cause is determined to be contamination due to improper handling by the customer.The contamination can temporarily lead to the complained error.

• Brand Name: COAGUCHEK XS PROF KIT
• Common Device Name: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7955352
• Report Number: 1823260-2018-03546
• Device Sequence Number: 1514078
• 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: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2019

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: Lay User/Patient
• Device Catalogue Number: 04837975001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1