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

Catalog Number 04625315160

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Coagulation Disorder (1779)

Event Date 01/19/2014

Event Type  Injury  

Event Description

Patient reported he had a rectal bleed.He then tested right away and got a result of 2.7 inr on the coaguchek xs system.His wife took him to the hospital.He was airlifted after he got to the first hospital.Customer received a colonoscopy, a blood transfusion, and fresh frozen plasma.He was in the icu for 4 days.His inr was within his normal range of 2.0 to 3.0 inr while he was in the hospital.He does not remember the time frame between the result of 2.7 inr on his meter, and the results between 2.0 to 3.0 inr in the hospital.Customer has since recovered and is currently feeling fine.Requested return of suspect system and replacement was 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: 3854021
• MDR Text Key: 4616946
• Report Number: 1823260-2014-04134
• 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: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2014

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: Lay User/Patient
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: 04625315160
• Device Lot Number: 22222111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 06/06/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/03/2014; 07/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WARFARIN; IMURAN; PREDNISONE; ASPIRIN; PRAVACHOL
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 070 YR
• Patient Weight: 64