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

Catalog Number 03666794001

Device Problem Image Display Error/Artifact (1304)

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

Event Date 06/12/2023

Event Type  malfunction  

Manufacturer Narrative

Section e3: occupation is patient/consumer.The reporter checked the old batteries that came with the meter and found that the ends had corrosion and rust.The meter and the corroded batteries were requested for investigation.The reporter will get a meter replacement.H3 other text : na.

Event Description

We received an allegation of a display issue on a coaguchek xs meter.The reporter alleged that since the meter's screen was faint, he changed batteries but then nothing comes up.During the call, the display was checked but the meter did not power on.The reporter was advised to change the batteries with a second set of new batteries.The meter then powered on but only for a second.The reporter saw ee in the upper left corner of the screen.He also noticed that all segments were missing in the results field and the screen looked faint.The reporter checked the meter memory and could not see any results in the memory.

Manufacturer Narrative

Sections d9 and h3 were updated.The meter was provided for investigation.The meter did not turn on during investigation, therefore the error log could not be read out.The meter was disassembled for further investigations.The optical inspection of the printed circuit board revealed contamination due to residues of fluid ingress (e.G.Leaked battery acid, cleaning solution,.).The contamination on the battery contacts caused a power interruption.Therefore, it was not possible to turn the meter on.Furthermore, the contamination can lead to the reported problem with the faded / missing segments.The residues were visible in the area on the printed circuit where communication with the display took place.The root cause was a contamination of the contacts due to an improper handling or maintenance.The investigation deterrmined that the issue was due to a user error.

• 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: 17279717
• MDR Text Key: 318792677
• Report Number: 1823260-2023-02202
• Device Sequence Number: 1
• Product Code: GJS
• 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: 07/25/2023

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: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 07/20/2023
• Supplement Dates FDA Received: 07/25/2023
• 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