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

Model Number COAGUCHEK XS PST

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

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

Event Date 12/08/2022

Event Type  malfunction  

Event Description

We received an allegation of a display issue on a coaguchek xs meter.The patient alleged that she gets either a 1.3 inr or 3.1 inr each time she tests.Upon review of the meter memory, there was only one result within the last 5 that matched that allegation (1.3 inr on (b)(6) 2022).The patient alleged that after she gets the results that are there in the meter memory, she powers the meter off using the "i" button and back on, and she will see a different result in the results field.The patient turned the meter off using the "i" button and then back on.The patient alleged a result of 2.1 display with no unit of measure (no inr, sec, or %q).A display check was performed.The patient clearly read the three 8's in the results field.There were no missing or abnormal segments.Once the "i" button was released after the display check, the patient saw 2.1 on the screen again where the three 8s had been.

Manufacturer Narrative

Initial reporter occupation is patient/consumer.The patient's meter was requested for investigation.

Manufacturer Narrative

The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause could not be determined.

• 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: 16072853
• MDR Text Key: 308290092
• Report Number: 1823260-2022-04237
• 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: 02/22/2023

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: COAGUCHEK XS PST
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 02/22/2023
• 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