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

Catalog Number 03666794001

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi) (b)(4).Occupation is lay user/patient the reporter's meter was provided for investigation where it was tested using retention strips and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.1 inr qc 2: 5.2 inr qc 3: 5.3 inr the obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The meter's error memory was reviewed and no error 5 or error 7 messages were observed at the same time as a result.No other errors were observed.The control testing was saved in the meter memory correctly.A full display check was performed and observed no missing segments or display issues.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter complained of a display issue with coaguchek xs meter serial number(b)(4).Customer stated they initially received an error 5 message on the meter during a test.Error 5 can indicate not enough blood was applied to the test strip.Customer tested again and received a result of 5.2 inr and the customer stated this result then switched to an error 7 on the display.No segments were missing from the meter display.The allegation could lead to misinterpretation of results.

• 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: 11331935
• MDR Text Key: 255006730
• Report Number: 1823260-2021-00475
• 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: 02/16/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/16/2021
• 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