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

Catalog Number 04625315160

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemoptysis (1887); Vomiting (2144)

Event Date 01/09/2015

Event Type  Injury  

Event Description

Caller reported that they received a value of 1.9 inr on the coaguchek xs system for a patient at 0600.At 2025, the patient experienced hematemesis and was transferred to the hospital for evaluation and treatment.At this time a lab draw was done and returned a value of > 20 inr.Patient was hospitalized for a gi bleed.Requested return of supect device and replacment sent.

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.

• 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: 4484730
• MDR Text Key: 17939216
• Report Number: 1823260-2015-00863
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Unknown
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 04625315160
• Device Lot Number: 22907011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Long-Term Care Facility
• Initial Date Manufacturer Received: 01/10/2015
• Initial Date FDA Received: 02/04/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/16/2015; 03/23/2015
• 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; TAMIFLU; MULTI-VITAMIN; LACTOBACILLUS; DUONEB; AUGMENTIN
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 098 YR
• Patient Weight: 52