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

Catalog Number 04625315160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation is lay user/patient.

Event Description

The customer complained of discrepant inr results with coaguchek xs meter serial number (b)(4) compared to the laboratory.The customer tested on the meter and got a result of 7.1 inr.The result from the laboratory within 1 hour was 4.54 inr.The customer's therapeutic range is 4 - 4.5 inr.The customer stated she is being treated for deep vein thrombosis (x3) and has a clotted optic nerve.The customer has antiphospholipid antibodies.The customer stated that due to her tendency to clot due to antiphospholipid antibodies, she developed a clotted optic nerve.The customer refused to provide any additional inr results related to the clotted optic nerve or deep vein thrombosis.The customer would not provide any specific treatment details.There is no information to reasonably suggest the device caused or contributed to an adverse event.The customer has not had any changes in diet and is not taking any new medications.The customer does not have lupus.The customer is not anemic.The customer occasionally takes heparin if her inr is outside of her normal range.The customer is not experiencing any bleeding or bruising.The meter and test strips were requested for investigation.The customer refused to return the meter.Relevant retention test strips (lot 304973) 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.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.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
• 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: 7909968
• MDR Text Key: 121866843
• Report Number: 1823260-2018-03300
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702128101
• UDI-Public: 00365702128101
• 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: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 04625315160
• Device Lot Number: 30497311
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2018
• 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
• Removal/Correction Number: 1823260-08/30/18-005-C
• Patient Sequence Number: 1