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	10/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The customer complained of issues with two of their coaguchek xs meters that may impact the interpretation of their results.This medwatch will cover the meter with serial number (b)(4).For information on the meter with serial number (b)(4) please refer to the medwatch with patient identifier (b)(6).The meter initially had no power.The customer replaced the batteries and performed a display check.Missing segments were noted during the display check which could affect the interpretation of results.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 returned for further investigation.The investigation is currently ongoing.
Additional Manufacturer Narrative
The customer returned the meter for investigation.The display shows no error and no missing or faded segments.The circuit board shows no contamination.The investigation did not identify a product problem.The cause of the event 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
• MDR Report Key: 8041175
• Report Number: 1823260-2018-04082
• Device Sequence Number: 1498995
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1