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

Catalog Number 04625412019

Device Problem Display Difficult to Read (1181)

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

Event Date 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

The customer's meter was requested for investigation.Medwatch field e3.Occupation - the occupation is patient/consumer.H3 other text : na.

Event Description

It was reported that there was an issue with the display of coaguchek xs meter serial number (b)(6).The display of the meter, including the results field, was missing segments.There was no allegation of a result misinterpretation.

Manufacturer Narrative

The meter was returned for investigation.The circuit board showed contamination caused by a penetrating liquid and this affected the conductive rubber contacts.The display segments were faded and unreadable in all areas of the display.The battery contacts were found to be contaminated by a leaked battery.The investigation determined the issue was related to a mishandling of the device.Per product labeling: "if you store the meter for a period of time, remove the batteries.Use the meter at a relative humidity of less than 85%, without condensation." "please follow the procedures below to clean and disinfect the meter.Failure to follow these procedures may cause malfunction of the meter.Clean the meter only when contaminated with blood.Do not use sprays of any sort.Ensure that swab or cloth is only damp, not wet." 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: 16904143
• MDR Text Key: 314936241
• Report Number: 1823260-2023-01584
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

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 Catalogue Number: 04625412019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 06/02/2023
• 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
• Patient Sequence Number: 1