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

Model Number XS PST

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation is lay user/patient.The meter was requested for investigation.The customer's returned meter was provided for investigation where it was tested using retention strips and retention controls.Testing results (qc range = 4.1 ¿ 6.8 inr): qc 1: 4.9 inr.Qc 2: 5.1 inr.Qc 2: 4.9 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The results alleged by the customer were observed in the meter¿s patient result memory.

Event Description

There was a complaint of a meter memory discrepancy with coaguchek xs meter serial number (b)(4).The customer¿s husband tested on the meter at 6:33 p.M.With a result of 3.7 inr.The customer¿s result from the meter at 6:36 p.M.Was 4.9 inr.The customer¿s result from the meter at 6:48 p.M.Was 4.6 inr.Upon reviewing the meter memory, there was an additional result of 3.8 inr at 6:30 p.M.The customer advised that neither she nor her husband received this result.

Manufacturer Narrative

The returned meter was investigated.The measurement mentioned by the customer is one of four measurements in the patient result log, that were successfully carried out on that day.The sequence number for all four measurements are continuous.No errors were observed in the error log.The result mentioned can only occurr after a successful measurement based on the timing and sequence number of the tests.An artificial creation of a measurement result can be ruled out.Qc measurements were all successfully completed and show no deviations.The device shows no error.

• Brand Name: COAGUCHEK XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12191662
• MDR Text Key: 272238457
• Report Number: 1823260-2021-02094
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: XS PST
• Device Catalogue Number: 04837738001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1