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 07/13/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: occupation is patient/consumer.There was no moisture or debris in the battery compartment.The heater plate was clean and dry.The meter was requested for investigation.

Event Description

We received an allegation of a display issue with a coaguchek xs meter.On (b)(6) 2022 the result in the meter memory looked like 8.2 inr.The result was actually 3.2 inr.The patient reported a result of 8.2 inr; the patient held her medication for one night.The patient was not harmed by holding her medication.On (b)(6) 2022 the result in the meter memory looked like 11.9 inr.The result was actually 1.9 inr.The patient reported a result of 11.9 inr; no medication changes were made.The patient went to the doctor where the result from an unknown method was also 1.9 inr.The patient stated her vision is poor and she can¿t read the results correctly.She stated when she tilts the meter she is able to see the correct results.A display check was performed and the display was complete with no missing segments.

Manufacturer Narrative

The meter was received for investigation.The meter display was examined and the segments showed a weak contrast.The non-active segments may also appear faint.The investigation found contamination of the conductive rubber contacts which leads to the issue observed.The cause of the event was the contamination of the contacts which is due to improper customer 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: 15456939
• MDR Text Key: 306417325
• Report Number: 1823260-2022-02885
• 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: 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 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: 08/25/2022
• Initial Date FDA Received: 09/20/2022
• 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
• Patient Sex: Female