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

Catalog Number 04625374160

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The customer stated that they received discrepant inr results on a coaguchek xs meter with serial number (b)(4).The customer stated that he did not receive an error or a result and the meter continued to count down.The customer changed the batteries.The customer attempted to test himself but received an error indicating not enough blood as the blood did not fill the channel.At 02:21 pm the customer retested and the result from the meter was 6.7 inr.The customer did not believe the result was possible.The customer tested himself again but received an error message indicating not enough blood as the blood did not fill the channel.At 02:35 pm the customer tested himself with a different fingerstick and the result from the meter was 2.9 inr.There was no allegation of an adverse event.The customer was not anemic, no heparin, no antiphospholipid antibodies, and no direct thrombin inhibitors.The customer has had no changes in diet, no illness, no new medications, no bleeding, and no bruising.The customer's therapeutic range was 2.0-3.0 inr.The suspect product was requested to be returned for investigation.

Manufacturer Narrative

The customer returned both meter and strips for investigation.The returned meter and strips were tested in comparison to a retention meter and masterlot strips.Two human blood samples from warfarin donors and internal reference meters were used.Donor 1 inr: 2.7 inr.Donor 2 inr: 2.2 inr.Donor 1 hct: 38%.Donor 2 hct: 48%.Testing results: donor 1: retention meter with masterlot strips: 2.7 inr.Customer meter with customer strips: 2.7 inr.Donor 2: retention meter with masterlot strips: 2.2 inr.Customer meter with customer strips: 2.2 inr.All inr values were within the specified maximum difference between measurements.No error messages occurred.The returned and the retention material meet the specifications.Relevant retention test strips (lot 272164) were tested in comparison with the current master lot at roche mannheim.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.

• 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: 7578329
• MDR Text Key: 110733956
• Report Number: 1823260-2018-01779
• Device Sequence Number: 1
• Product Code: GJS
• 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: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 04625374160
• Device Lot Number: 27216421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Date Manufacturer Received: 05/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 129