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

Catalog Number 07671687019

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

Reporter occupation is lay user/patient.The patient purchased the meter from an outside source, not from an approved distributor.The patient also stated the test strips are purchased "online" but does not know where.The test strips were requested for investigation.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.Relevant retention test strips (lot 405011) were tested in comparison with the master lot coaguchek xs pt.For this purpose, two human blood samples from marcumar donors and two internal reference meters were used.Retention samples were acceptable.No error messages occurred.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter complained of discrepant inr results with coaguchek xs meter serial number (b)(4), compared to a coumadin clinic unknown roche meter.The result from the clinic's meter 3:30 p.M.- 4:00 p.M.Was 2.3 inr.The result from the patient's meter between 6:30 p.M.- 7:00 p.M.Was 1.6 inr.The patient's dose was slightly decreased by the doctor based on the reading from the clinic meter.The patient's therapeutic range was 1.5 - 2.0 inr.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• 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: 9592302
• MDR Text Key: 204194468
• Report Number: 1823260-2020-00138
• 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: Other
• Type of Report: Initial
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 07671687019
• Device Lot Number: 40501113
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 47 YR