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

Catalog Number 04625315003

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Occupation is lay user/patient.The test strips were requested for investigation.Two vials of the reporter's test strips were provided for investigation where they were tested using retention controls.Testing results (qc range: 2.6 - 3.2 inr): vial #1 qc 1: 3.0 inr, qc 2: 3.0 inr, qc 3: 3.0 inr.Vial #2 qc 1: 3.0 inr, qc 2: 2.9 inr, qc 3: 2.9 inr.Relevant retention test strips (lot 397397) 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.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 investigation did not identify a product problem.The cause of the event could not be determined.Per product labeling, "coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods.

Event Description

The initial reporter complained of discrepant inr results with coaguchek xs meter serial number (b)(4) compared to an unknown laboratory method.On (b)(6) 2019 the result from the laboratory was 2.85 inr.The result from the meter within two hours was 8.0 inr.An additional result from the meter was 8.0 inr.On (b)(6) 2020 the result from the meter at 6:13 a.M.Was 8.0 inr.The result from the laboratory at 8:00 a.M.Was 3.86 inr.The result from the meter at 9:02 a.M.Was 8.0 inr.The patient's therapeutic range was 2.0 - 3.0 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: 9637409
• MDR Text Key: 219782493
• Report Number: 1823260-2020-00215
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2020

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: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 04625315003
• Device Lot Number: 39739711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Date Manufacturer Received: 01/03/2020
• 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: 73 YR
• Patient Weight: 92