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

Catalog Number 03666794001

Device Problem Unexpected Therapeutic Results (1631)

Event Date 12/30/2020

Event Type  malfunction  

Manufacturer Narrative

A display test was performed and there were no display issues, all segments were present.The customer's meter was requested for investigation.Occupation is lay user/patient.The investigation is ongoing.

Event Description

The initial reporter called to ensure her meter was in the correct unit of measure.She stated she received a result of 22.4sec but the result was not in the meter's memory.The customer was unable to determine what her result was in inr.Her result only appeared in seconds, then was not retrievable in meter memory.During the review of her meter memory, she observed: on (b)(6) 2020 at 12:35pm the meter result was 1.8 inr / 22.1sec.The customer alleged this result was from the previous week.The customer's date and time on the meter were set incorrectly.On (b)(6) 2020 at 2:21pm the meter result was 1.9 inr.The alleged result of 22.4sec could not be found in the meter's memory.The customer's therapeutic range was requested but not provided.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 11220090
• MDR Text Key: 244577848
• Report Number: 1823260-2021-00246
• 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
• Report Date: 01/22/2021

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?: No
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/23/2021
• 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