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

Model Number XS PST

Device Problem Image Display Error/Artifact (1304)

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

Event Date 06/30/2023

Event Type  malfunction  

Manufacturer Narrative

E3-occupation is patient/consumer.The investigation is ongoing.

Event Description

The customer complained of discrepant inr results with coaguchek xs meter serial number (b)(6) compared to a laboratory using an unknown reagent.The meter display has missing segments in the last number on the right side of the results area.Customer stated it looked like the right half of the number is visible and the left side is faded.There was no misinterpretation of results reported.

Manufacturer Narrative

The meter was returned for investigation.The investigation found that the battery contacts as well as the circuit board are contaminated by liquid that has penetrated/corroded the solder contacts.This affects the battery contacts on the circuit board, which are interrupted by this and the conductive rubber contacts the cause of the issue is customer mishandling.Medwatch fields d9 and h3 have been updated.

• 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: 17373770
• MDR Text Key: 319742219
• Report Number: 1823260-2023-02402
• 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: 10/26/2023

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1