MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK LINK; CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE

Catalog Number 06216340001

Device Problems Loss of Data (2903); Patient Data Problem (3197)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

On approximately one week prior to (b)(6) 2017 (date unknown), the patient received notification that results from his coaguchek meter (unknown serial number) were not being reported in the coaguchek link (software version 1.06).The patient says he was confident that he reported the results successfully in coaguchek link and stated that there are missing and incorrect results in the result history.The patient and the memory of the coaguchek meter both confirmed that tests were completed on (b)(6) 2017.At 11:56 a.M.On (b)(6) 2017, the result was 3.8 inr.At 12:16 p.M.On (b)(6) 2017, the result was 2.4 inr.The patient states that he reported these results as normal in the coaguchek link and believes that the results were missing from the chart in error.When checking the link, these results were not present.The link result history also showed 3 results reported on (b)(6) 2017.Two results were duplicates and the patient did not recall inputting these two results.The two results also did not show in the memory of the coaguchek meter.The correct value measured on (b)(6) 2017 was 3.3 int at 12:15 p.M.This value also is present in the meter memory.The two duplicate values that the patient did not believe he input in the link on (b)(6) 2017 were 3.7 inr at 11:05 a.M.These values were not present in the meter memory.The patient did not take any actions based on the issue as he assumed that results were being reported correctly.He did not seek medical treatment and was not injured.No adverse events were alleged to have occurred with the patient.The patient continued his normal coumadin dosage until receiving notification that results were not being reported.After receiving the notification, he input results and spoke with his physician.No changes were made in the patient's treatment.The patient's therapeutic range is 2.5 - 3.5 inr.The patient's testing frequency is 2 to 4 tests per month.

Manufacturer Narrative

Investigations have determined that there has been no discrepancy with the patient's results in coaguchek link.The claim made by the patient was not confirmed as the audit log shows the entries that were claimed to be missing.There was also no evidence to confirm that a test result of 3.8 inr had been generated on (b)(6) 2017 at 11:56 a.M.No issue with the coaguchek link application was identified and the application is working according to specification.

• Brand Name: COAGUCHEK LINK
• Type of Device: CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE
• 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: 7193651
• MDR Text Key: 97878434
• Report Number: 1823260-2018-00144
• Device Sequence Number: 0
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 06216340001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2017
• 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