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

Catalog Number 04625315019

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The meter and 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 409643) 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 back to back inr results with coaguchek xs plus meters serial number (b)(4), compared to an unknown laboratory method.The result from the meter (b)(4) was 6.1 inr.The result from the meter (b)(4) was 2.1 inr.The result from the laboratory was 1.9 inr.The tests were back to back tests.The patient has a therapeutic range of 2.0 - 3.0 inr.The patient was taking an antibiotic until (b)(6) 2019.

Manufacturer Narrative

The reporter's meters and strips were returned for investigation.The returned test strips were measured with the returned meters in comparison with the current test strip master lot.For each customer meter two measurements were made.For this purpose two human blood samples from marcumar donors and internal reference meters were used.Donor 1 hct: 52% , donor 2 hct: 45%.Testing results: donor #1: retention meter and master lot strips: 1.7 inr , customer meter uq0092710 and customer strips: 1.6 inr, customer meter uq0099871 and customer strips: 1.6 inr.Donor #2: retention meter and master lot strips: 3.9 inr , customer meter uq0092710 and customer strips: 3.8 inr , customer meter uq0099871 and customer strips: 3.6 inr.All inr values were within the specified maximum difference between measurements.No error messages occurred.The returned material and the retention material meet specifications.Medwatch fields d10 and h3 have been updated.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9637424
• MDR Text Key: 219782633
• Report Number: 1823260-2020-00212
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 04625315019
• Device Lot Number: 40964313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANTIBIOTICS; WARFARIN.