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

Catalog Number 04625374160

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

The reporter's product was requested for investigation and replacement product was sent to the reporter.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.Medwatch field occupation: the occupation is lay user/patient.

Event Description

The initial reporter stated they received a discrepant result when testing with coaguchek xs meter serial number (b)(4).At 9:10 a.M., a sample from the patient was tested using the meter, resulting with a value of 7.6 inr.At 11:00 a.M., a sample from the patient was tested in the laboratory using an unknown method, resulting with a value of 5.6 inr.The patient's doctor advised the patient not to take warfarin for 2 days based on the laboratory value of 5.6 inr.The patient's therapeutic range is 2.5 - 3.5 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: 10614220
• MDR Text Key: 209416296
• Report Number: 1823260-2020-02414
• 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: 10/01/2020

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: 05/31/2021
• Device Catalogue Number: 04625374160
• Device Lot Number: 44009621
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/01/2020
• 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
• Treatment: ARTIFICIAL HEART VALVE; CARVEDILOL; IRON; LISINOPRIL; TAMSULOSIN; VITAMIN D3; WARFARIN
• Patient Age: 65 YR
• Patient Weight: 84