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

Model Number XS PST

Device Problem Circuit Failure (1089)

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

Event Date 04/30/2021

Event Type  malfunction  

Manufacturer Narrative

The reporter's meter was provided for investigation where it was tested using retention strips and retention controls.Testing results (qc range = 2.1 - 3.3 inr): qc 1: 3.0 inr, qc 2: 3.0 inr, qc 3: 2.7 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 memory was downloaded and the qc results were observed in the meter memory appropriately.No errors or defects observed.The only result of 1.9 inr in the meter memory was found on 21-apr-2021.Routine retention testing was performed.Test strip retention samples passed the internal inspection.The allegation could not be substantiated.The returned and the retention material met the specification.Initial reporter occupation was lay user/patient.Unique identifier (udi) #: (b)(4).

Event Description

There was an allegation of results displayed in the coaguchek xs meter memory not matching the result the customer received during testing.The customer stated the results in the meter memory for (b)(6) 2021 and (b)(6) 2021 were shown as 1.2 inr.The customer alleged the result should actually be 1.9 inr.On an unknown date and time, the result from a "nurse's meter" was 2.0 inr.

• 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: 12053382
• MDR Text Key: 271081906
• Report Number: 1823260-2021-01809
• 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: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• 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: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Date Manufacturer Received: 06/01/2021
• 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