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

Catalog Number 04625374160

Device Problems Unexpected Therapeutic Results (1631); High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2015

Event Type  malfunction  

Event Description

The customer's daughter called and reported that the customer obtained a result of 6.4 inr on her coaguchek xs meter (serial number (b)(4)) while the lab obtained a result of 3.0 inr on their coaguchek meter (unknown serial number).The results were taken 69 minutes apart and separate fingers were used for each test.The customer's daughter is not sure of the customer's therapeutic inr range and she stated they are currently waiting for a call from the doctor as to whether or not there will be any change in the customer's warfarin dose.She also reported that the customer's finger had to be squeezed to get the blood out.No special or unusual diet was reported.The customer is currently fine and does not have any bruising or bleeding at this time.The suspect product was requested to be returned and replacement was sent.The customer returned the strips, and the investigation of the customer strips and the retention master lot of strips showed that all inr values were within the specified maximum difference between measurements.

• 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) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5221318
• MDR Text Key: 31075893
• Report Number: 1823260-2015-04535
• 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
• Report Date: 11/12/2015

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: Lay User/Patient
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 04625374160
• Device Lot Number: 23194922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AMLODIPINE
• Patient Age: 091 YR
• Patient Weight: 52