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

Catalog Number	05021537001
Medical Device Problem Code	Display Difficult to Read (1181)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation is lay user/patient.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).Customer stated the meter display is black with a bit of blue at the bottom of the screen.Customer stated the issue could impede the ability to read the results.There was no allegation that any test results had been misinterpreted.
Additional Manufacturer Narrative
Customer's meter was returned for investigation.Meter powered on without difficulty with fresh retention batteries.Observed no display issues or malfunctions.Touchscreen was responsive and navigation through the meter's menu was without difficulty.The reporter's meter was tested using retention strips and retention controls.Testing results (qc range = 2.4 - 3.6 inr): qc 1: 3.0 inr.Qc 2: 3.0 inr.Qc 3: 3.0 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.No power or display issues were observed.The alleged malfunction was not reproducible.The product performed according to the specifications.Medwatch fields d9 and h3 have been updated.

• Brand Name: COAGUCHEK XS PLUS
• Common Device Name: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12507757
• Report Number: 1823260-2021-02754
• Device Sequence Number: 14470274
• 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
• 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): 10/19/2021

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: 05021537001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1