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 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer's daughter complained of questionable inr results from coaguchek xs meter serial number (b)(4).At 11:04 the result from the meter was 7.8 inr.At 11:06 the from the meter result was 5.3 inr.There was no allegation of an adverse event.The customer did not have issues with hematocrit, no other blood thinners, no antiphospholipid antibodies, no lupus, and no direct thrombin inhibitors.The customer recently began taking anti-inflammatory medications for health concerns unrelated to the meter results.The therapeutic range was 2.0 - 3.0 inr.The suspect product was requested to be returned for investigation however the test trips are no longer available.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: 2.6 inr donor 2 inr: 2.3 inr donor 1 hct: 40% donor 2 hct: 44% testing results: donor 1: retention meter with masterlot strips: 2.6 inr donor 1: customer meter with masterlot strips: 2.6 inr donor 2: retention meter with masterlot strips: 2.3 inr donor 2: customer meter with masterlot strips: 2.3 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.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.No information was provided in the complaint that would point to a cause for the result discrepancy.

• 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: 7548489
• MDR Text Key: 109907233
• Report Number: 1823260-2018-01615
• 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: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• 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: 272164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2018
• 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
• Patient Age: 82 YR
• Patient Weight: 77