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 04/15/2023

Event Type  malfunction  

Manufacturer Narrative

Occupation is patient/consumer.The meter was requested for investigation.

Event Description

We received an allegation of a display issue on a coaguchek xs meter.The patient alleged missing segments in the results field of the meter and a foggy display screen.The patient first noticed the foggy screen on (b)(6) 2023.The patient stated that when she inserted the strip, the screen was foggy and the first digit of the code number 1 was foggy but she could read it.A display check was performed and it was confirmed that there were no missing segments in the results field of the meter.The last result in the meter memory was checked and the bottom segment of the 2 was missing from a result of 2.9 inr.There was no misinterpretation of this result as she could tell it was a 2.

Manufacturer Narrative

Sections d9 and h3 were updated.The meter was provided for investigation.The device data and the error log were read out.A display test was performed and showed many segments with a weak contrast.The circuit board was tested for damage or contamination.The investigation showed that the battery contacts and the circuit board were contaminated by liquid (leaked battery) which has penetrated / corroded solder contacts.The conductive rubber contacts on the circuit board was short-circuited.The root cause of the missing segments was contamination of the contacts due to an 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: 17016417
• MDR Text Key: 317149217
• Report Number: 1823260-2023-01769
• 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: 05/01/2023
• Initial Date FDA Received: 05/29/2023
• 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: Female