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	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The meter was requested for investigation.
Event or Problem Description
The initial reporter complained of a display issue with coaguchek xs meter serial number (b)(4).The customer stated when a test strip is inserted into the device, the code number displayed, but it was faded and the middle number was hard to read.The code number makes up the segments of the results field.This issue could cause the misinterpretation of test results.There was no allegation that any test results had been misinterpreted.
Additional Manufacturer Narrative
The customer's meter was received for investigation.The meter¿s circuit board was tested for damage or contamination and it was found the printed circuit board (pcb) was contaminated.The root cause is determined to be contamination of the conductive rubber contacts due to liquid from improper handling or maintenance by the customer.Medwatch fields d9 and h3 were updated.

• 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: 12369452
• Report Number: 1823260-2021-02472
• Device Sequence Number: 16452026
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1