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

Catalog Number 04625374160

Device Problem No Apparent Adverse Event (3189)

Patient Problem Infarction, Cerebral (1771)

Event Date 02/15/2014

Event Type  Injury  

Event Description

Customer tested on the coaguchek xs system on (b)(6) 2014 at approximately 6:00 am and received a result of 2.0 inr.No action was taken based on this result.On (b)(6) 2014, the customer had an ischemic stroke and was admitted to the hospital.A lab test was performed on (b)(6) 2014 where a result of 1.4 inr was returned.No treatment information has been provided.The customer spent 5 days in the intensive care unit out of a total hospital stay of 3 weeks.The customer has since been released.The manufacturer requested return of suspect product for evaluation.

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: 3790067
• MDR Text Key: 16915051
• Report Number: 1823260-2014-03168
• 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 Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Unknown
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: 04625374160
• Device Lot Number: 21924421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CALCIUM; METOPROLOL; SYNTHROID; DOC-Q-LACE; EVISTA; COUMADIN; MINOCICLINA; VITAMIN D; DIGOXIN
• Patient Outcome(s): Hospitalization
• Patient Age: 070 YR
• Patient Weight: 57