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

Catalog Number 04625374160

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

The customer's test strips were requested for investigation, but are not expected to be returned due to the customer using all of the strips from the vial.The product has not been received at this time.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.Occupation is lay user/patient.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter received questionable results from coaguchek vantus meter serial number (b)(4).At 10:52am the meter result was 1.9 inr.During the call with the customer at approximately 2:38pm, the customer repeated the test using a different finger and received the meter result of 2.6 inr.The customer's therapeutic range is 3.0-4.0 inr.

• Brand Name: COAGUCHEK XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• 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: 11021990
• MDR Text Key: 244340322
• Report Number: 1823260-2020-03257
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170960
• 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: 12/16/2020

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 Expiration Date: 06/30/2021
• Device Catalogue Number: 04625374160
• Device Lot Number: 44949822
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/16/2020
• 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 Age: 59 YR
• Patient Weight: 96