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

Catalog Number 04625374160

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

The expiration date for strip lot 38560522 is 30-sep-2020.The test strips and meter were requested for investigation.The returned test strips were measured with the returned meter in comparison with the current test strip masterlot.For this purpose two human blood samples from warfarin donors and internal reference meters were used.Donor 1 inr: 2.8 inr, donor 2 inr: 2.2 inr.Donor 1 hct: 35%, donor 2 hct: 38%.Testing results: strip lot: 385605-22.Donor #1: retention meter and master lot strips: 2.8 inr.Customer meter and customer strips: 2.8 inr.Donor #2: retention meter and master lot strips: 2.2 inr.Customer meter and customer strips: 2.2 inr.Strip lot: 397398-21.Donor #1: retention meter and master lot strips: 2.8 inr.Customer meter and customer strips: 2.8 inr.Donor #2: retention meter and master lot strips: 2.2 inr.Customer meter and customer strips: 2.2 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.The result of 5.3 inr was not observed in the meter's patient result memory.Relevant retention test strips (lot 397398 and 385605) 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 meter serial number (b)(4) using two different strip lots.The result using strip lot 38560522 and the meter at 11:30 a.M.Was 3.7 inr.The result using strip lot 39739821 and the meter at 01:30 p.M.Was 5.3 inr.The patient's therapeutic range of 2.0 - 3.0 inr.The customer is using a topical steroid.

• 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: 9616235
• MDR Text Key: 219780514
• Report Number: 1823260-2020-00178
• 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: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 04625374160
• Device Lot Number: 39739821, 38560522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Date Manufacturer Received: 12/27/2019
• 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: 91 YR