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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation - the occupation is lay user/patient.

Event Description

The customer complained of discrepant inr results for 1 patient from caoguchek xs meter serial number (b)(4) compared to the laboratory result.At 06:31 am, the result from the meter was 5.0 inr.The result from the laboratory was 2.9 inr.The specific time of the laboratory collection was not provided.There was no allegation of an adverse event.The patient was "healthy".The qc was acceptable.The patient was not anemic, had no heparin, no antiphospholipid antibodies, and no lupus.The patient's therapeutic range was 2 - 3 inr.The suspect product was requested to be returned for investigation.Retention test strips (lot 286319) were tested in comparison to master lot #28632180.For this purpose, two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.Retention material complies with specification.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 recall - correction/removal report no.

Manufacturer Narrative

The customers's meter and strips were returned for investigation.Testing results: vial#1 qc 1: 2.4 inr, qc 2: 2.5 inr, qc 3: 2.4 inr.Vial #2 qc 1: 2.5 inr, qc 2: 2.4 inr.Retention strips: qc 3: 2.5 inr.The obtained qc values were in the allowed range of the used combination master lot strip lot - qc lot.1.9 - 2.9 inr.All measurements were without error messages.The maximum difference between measurements was 4.0 %.No information was provided in the complaint case that would point to a cause for the result discrepancy.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.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: 7918081
• MDR Text Key: 122010023
• Report Number: 1823260-2018-03330
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: 28631921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Date Manufacturer Received: 09/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1823260-08/30/18-005-C
• Patient Sequence Number: 1
• Treatment: STEROID TREATMENT; STEROID TREATMENT