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

Catalog Number 04625374160

Device Problems Device Difficult to Setup or Prepare (1487); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhagic Stroke (4417)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.The reporter initially called for assistance setting the date and time on the meter after replacing the batteries.The date/time settings of the meter will be lost when changing the meter batteries takes longer than 1 minute.Setting up the meter date and time is explained in the product labeling.Medwatch field e3.Occupation - the occupation is patient/consumer.

Event Description

It was alleged that a patient had two hematomas in the brain in (b)(6)2018 when using coaguchek xs meter serial number (b)(6).The specific date of the event is not known.The patient's doctors reportedly found 2 hematomas in the patient's brain in august 2018.The patient's inr before hospitalization and at the hospital are not known.The patient was reportedly testing once per month when the event occurred.The patient reportedly received a vitamin k injection and was on a heparin drip for surgery.The patient's doctors reportedly advised they did not know what caused the brain bleed, but the hematomas shifted the patient's brain 0.5 inches and the patient required surgery to have one hematoma removed.The patient's doctors reportedly advised that the other hematoma would dissolve on its own and it reportedly did dissolve.Upon discharge from the hospital, the patient was reportedly given heparin to take home to bridge and get her back within her therapeutic range.The patient's therapeutic range is reported as 2.5 - 3.5 inr.The patient's current interval of testing is reported to be weekly.This mdr is being submitted in an abundance of caution.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16920343
• MDR Text Key: 315107141
• Report Number: 1823260-2023-01616
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• 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: Other
• Type of Report: Initial
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: 63658921
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2023
• 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
• Patient Sequence Number: 1
• Treatment: WARFARIN
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 64 KG