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

Catalog Number 04625315160

Device Problems High Test Results (2457); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2018

Event Type  malfunction  

Event Description

The customer stated that they performed comparison studies for a total of 12 different patients tested with a coaguchek xs plus meter (serial number unknown).Results from the meter were compared to results measured in the laboratory using the dade innovin method.Three patients had erroneous test results from the meter.The time frames between each sample measurement were asked for, but not provided.Patient 1 meter result was 4.5 inr.The laboratory result was 3.3 inr.On (b)(6) 2018, patient 2 meter result was 4.0 inr.The laboratory result was 3.0 inr.On (b)(6) 2018, patient 3 meter result was 6.6 inr.The laboratory result was 4.8 inr.No adverse events were alleged to have occurred with the patients.The customer's product was requested for investigation.Relevant retention test strips (lot 294943) were tested in comparison with the current master lot.For this purpose two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.Retention samples were acceptable.

Manufacturer Narrative

The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause could not be determined.Extensive measurements have shown higher deviations for coaguchek values > 4.5 inr compared to a laboratory method.Therefore, the customer allegation has been substantiated.A product problem has been found for coaguchek values > 4.5 inr, which was the case in this complaint.This can be traced back to the calibration of the complained test strips to the who standard rtf/16.For measurements > 4.5 inr.The customer is advised to contact the physician and perform a measurement with a laboratory method.Roche diagnostics has issued a recall for this issue.Please refer to medwatch field h9- correction/removal report no.

• 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: 7914043
• MDR Text Key: 121870095
• Report Number: 1823260-2018-03307
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702128101
• UDI-Public: 00365702128101
• 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: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04625315160
• Device Lot Number: 29494312
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1823260-08/30/18-005-C
• Patient Sequence Number: 1