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

Model Number XS PST

Device Problem Lack of Maintenance Documentation or Guidelines (2971)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2022

Event Type  malfunction  

Event Description

The initial reporter alleged they could not find instructions in the user manual for changing the unit of measure on the coaguchek xs meter.They also mentioned getting results in seconds (sec).On a follow-up call, the result pulled from the meter memory was 2.3 inr with an unknown strip lot on 11-jan-2022.The call agent reviewed how to change the unit of measure on the meter.At the time of the follow-up call, the user's meter was functioning properly and was correctly set to inr.

Manufacturer Narrative

Initial reporter occupation: occupation is patient/consumer (patient's wife).The meter is provided to u.S.Customers pre-set to the measuring unit inr.There are two additional measuring units on the meter: %quick (%q) and seconds (sec).In the u.S., the most accepted unit of measure is inr.Roche has communicated to all impacted customers instructions on how to confirm results are displayed in the measuring unit inr and the steps to take to change the measuring units back to inr if the meter is displaying the units sec or %q.

Manufacturer Narrative

Clarification was received that on the follow-up call the meter was already set to the correct units (inr).The reporter remembered receiving a letter about this issue and wanted to make sure there was no issue with the meter.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: 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: 15321807
• MDR Text Key: 305365531
• Report Number: 1823260-2022-02639
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: XS PST
• Device Catalogue Number: 04837738001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 08/31/2022
• Supplement Dates FDA Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 86951
• Patient Sequence Number: 1
• Patient Sex: Male