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

Catalog Number 03666794001

Device Problems Image Display Error/Artifact (1304); Non Reproducible Results (4029)

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

Event Date 08/30/2022

Event Type  malfunction  

Manufacturer Narrative

The customer's meter was requested for investigation and a replacement product was sent to the customer.Medwatch field occupation - the occupation is patient/consumer.

Event Description

It was reported that there was an issue with the display of coaguchek xs meter serial number (b)(4).A patient was tested with the meter between 8:00 a.M.And 9:00 a.M.On (b)(6) 2022 and it could not clearly be seen if the measured value was 1.6 inr or 1.8 inr.The meter batteries were changed and the meter was powered back on and in setup mode.When checking the display, the display setting for the date format of "12-31-00" appeared as 18-37-00.A display check was performed and 000's were observed in the results field instead of 888.When checking the meter's patient result memory the value from (b)(6) 2022 still could not be clearly seen, appearing as either 1.6 inr or 1.8 inr.

Manufacturer Narrative

The customer's meter was returned for investigation.Several segments on the display failed completely.All areas of the display are affected by the issue.The battery compartment of the meter had contamination from a leaked battery and the circuit board was contaminated by liquid penetrating in several places.The contamination interrupts some conductive rubber contacts.The contamination issue would be caused by a mishandling of the device.

• 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: 15470911
• MDR Text Key: 306088318
• Report Number: 1823260-2022-02909
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• 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: 11/07/2022

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 Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 10/28/2022
• Supplement Dates FDA Received: 11/07/2022
• 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
• Patient Sequence Number: 1