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

Catalog Number 04625315160

Device Problem Improper Device Output (2953)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2015

Event Type  malfunction  

Event Description

Patient tested 3.8 inr on the coaguchek xs and 2.6 inr on a comparison lab.No actions taken based on device results.No adverse event reported.Requested return of suspect device; however, the strip that produced the result on the meter was the last strip in the vial of strips.

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.Strips no longer available.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4818718
• MDR Text Key: 5923073
• Report Number: 1823260-2015-03581
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/25/2015

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: Unknown
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 04625315160
• Device Lot Number: 22906711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2015
• Initial Date FDA Received: 06/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN