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 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device was requested for return but was not available.

Event Description

The customer complained of discrepant inr results from coaguchek xs meter serial number (b)(6).At 9:30 am the result from the meter was 1.6 inr.At 10:00 am the result from the meter was 2.3 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 coumadin dose has not changed.The customer's therapeutic range was 2.2 - 2.4 inr.The returned meter was tested in comparison to a retention meter and masterlot strips.Human blood samples from warfarin donors were used.Donor 1 inr: 2.3 inr, donor 2 inr: 2.0 inr.Donor 1 hct: 50%, donor 2 hct: 42%.Testing results: donor 1: retention meter with masterlot strips: 2.3 inr, donor 1: customer meter with masterlot strips: 2.3 inr.Donor 2: retention meter with masterlot strips: 2.0 inr, donor 2: customer meter with masterlot strips: 2.0 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.The investigation was unable to find a definitive root cause.Relevant retention test strips (lot 250332) 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.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
• 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: 7559978
• MDR Text Key: 109749515
• Report Number: 1823260-2018-01692
• Device Sequence Number: 1
• Product Code: GJS
• 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: Patient
• Type of Report: Initial
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 04625374160
• Device Lot Number: 25033221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/14/2018
• 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
• Patient Sequence Number: 1
• Treatment: COUMADIN
• Patient Age: 81 YR
• Patient Weight: 100