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

Catalog Number 04625315160

Device Problem Incorrect Measurement (1383)

Patient Problem Coagulation Disorder (1779)

Event Date 09/01/2018

Event Type  Injury  

Manufacturer Narrative

The reporter's product was requested for investigation.

Event Description

The initial reporter stated that a patient had unknown injuries arising out of a stroke suffered on (b)(6) 2018 as a result of using coaguchek xs pt test strip lot number 32264411.No details surrounding the event, including patient information or patient result data could be provided.

Manufacturer Narrative

As the customer's strips are expired, they cannot be investigated.This test strip lot has been fully investigated.The complained test strips have been calibrated against the who standard and are in scope of the roche initiated recall.For these test strips there is a potential for a product problem when the inr is > 4.5.Values > 4.5 inr showed an increasing positive bias.Investigations have indicated results are reliable from 0.8 to 4.5 inr, since the calibration data covers this measuring range very well.Medwatch field h9 has been updated.

Manufacturer Narrative

Request from fda: for 1823260-2020-02077, it is unclear why the event happened in (b)(6) 2018 but reported on 8/24/2020.Response from manufacturer: the event information was first received by roche in july, 2020 through a personal injury attorney for an event that happened in (b)(6) 2018.At this time, we have not received the product back and do not have additional information related to the event.In reviewing the case, we identified an error in the "become aware" date.The report was received by our legal department on july 20, 2020; however, the call agent used july 27, 2020, as the "become aware" date.The report was sent to fda on august 24, 2020.We take our mdr reporting obligations seriously and we have a process to identify the root cause of all late mdrs and to take appropriate actions to prevent recurrence in the future.This appears to have been an error when logging the information into the case handling tool.We will submit a supplemental report if we learn additional information about this event.Medwatch field g4.Has been updated.

• 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: 10443400
• MDR Text Key: 204256957
• Report Number: 1823260-2020-02077
• 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,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625315160
• Device Lot Number: 32264411
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 07/27/2020; 07/20/2020
• Supplement Dates FDA Received: 09/11/2020; 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES Z-0360-2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other