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 03/26/2021

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi) (b)(4).Occupation is lay user/patient.The meter was returned and forwarded for investigation.The investigation is ongoing.When the investigation is complete a follow up report will be submitted.

Event Description

The initial reporter complained of a memory issue with coaguchek xs meter serial number (b)(4).Customer stated they wrote down a result of 2.2 inr for their test on (b)(6) 2021.Meter memory displays a result of 3.7 inr obtained at 10:23 am on (b)(6) 2021.No result of 2.2 inr was observed in the meter memory on that date.The customer performed a display check and no segments were missing from the results field of the display.

Manufacturer Narrative

The reporter's meter was returned for investigation.Testing results (qc range: 2.5 ¿ 3.1 inr): qc 1: 2.6 inr qc 2: 2.6 inr qc 3: 2.6 inr testing results (qc range: 4.1 - 6.8 inr): qc 1: 5.5 inr qc 2: 5.5 inr qc 3: 5.4 inr all inr values were within the specified maximum difference between measurements.No error messages occurred.The returned material and the retention material meet specifications.The results mentioned by the patient were found in the meter´s patient result report.The only value saved in the memory on (b)(6) 2021 was 3.7 inr.The stated value 2.2 inr was not confirmed.The values measured during investigation were saved in the patient result report.As soon a measurement is finalized the value will be saved in the meter memory.A confirmed error between measured and saved values in the memory of a coaguchek meter has never been confirmed.

Manufacturer Narrative

The corrected results from the high level control sample are as follows: testing results (qc range: 2.5 ¿ 3.1 inr): qc 1: 2.9 inr; qc 2: 3.0 inr; qc 3: 3.0 inr.

• 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: 11778465
• MDR Text Key: 250067880
• Report Number: 1823260-2021-01358
• Device Sequence Number: 1
• Product Code: GJS
• 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,Followup
• Report Date: 07/08/2021

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: 04/22/2021
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 04/12/2021; 04/12/2021
• Supplement Dates FDA Received: 06/02/2021; 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALPRAZOLAM; ESCITALOPRAM; LOSARTAN; OMEPRAZOLE; PREDNISONE; ROSUVASTIN; VITAMIN D; WARFARIN
• Patient Age: 74 YR
• Patient Weight: 82