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 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

Section e3: occupation is patient/consumer.A replacement meter will be sent to the customer.The meter with the alleged display issue was requested for investigation.

Event Description

We received an allegation of a display issue on coaguchek xs meter.On 31-may-2023 the reporter alleged that when the meter is powered on the display was not bright.A display check was performed and "888" was displayed but it was slightly faded; from the left side down the middle, the 8's were missing.The reporter stated the results field could be seen in some light, in other light, the results field appeared as "999.".

Manufacturer Narrative

The meter was provided for investigation where the device data and fault memory were read out, a display test was performed and a circuit board was tested for damage or contamination.When examining the display, many segments were shown with a weak contrast.The battery contacts in the battery compartment and the circuit board were contaminated by liquid (leaked battery) which had penetrated / corroded solder contacts.The investigation determined that the root cause of the event was contamination of the conductive rubber contacts due to improper handling or maintenance.

• 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: 17221219
• MDR Text Key: 318350346
• Report Number: 1823260-2023-02105
• 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: 07/24/2023

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: 05/31/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 07/06/2023
• Supplement Dates FDA Received: 07/24/2023
• 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
• Patient Sex: Male