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

Catalog Number 04625374160

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Transient Ischemic Attack (2109); Insufficient Information (4580)

Event Date 10/31/2014

Event Type  Injury  

Manufacturer Narrative

The issue with setting the date and time was determined to be an issue with the "set" button on the meter.These issues were resolved by replacing the meter.The reporter alleged she had received an error 5 on the meter in the past.Per product labeling: error applying blood to the test strip.Turn the meter off and remove the test strip.Repeat the test using a new test strip and blood taken from a new fingerstick from a different finger.The meter and strips have been requested for return.Only the reporter's meter was provided for investigation where it was tested using retention strips and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.1 inr, qc 2: 5.3 inr, qc 3: 5.0 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.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.Occupation was patient/consumer.

Event Description

The initial reporter contacted technical support for assistance setting the date and time on coaguchek xs meter serial number (b)(4).While troubleshooting, the reporter mentioned previous events.The reporter has had the meter since 2013.The reporter allegedly had tia strokes in 2014, 2016, 2017, and 2020.The reporter could not provide any specific dates of the events.For the event in 2020, the reporter alleged she was at a picnic in the heat and got heatstroke, which caused the tia.The reporter did not provide any results from the meter at the time of any of the alleged events and did not report any issues with the meter at the time of these alleged events.The reporter could not provide any information on any treatments received.The therapeutic range was 2.0- 2.35 inr and testing was performed every two weeks.Additional information was requested but was not provided.This included why the reporter is on anticoagulation therapy, if the reporter had a mechanical heart valve, if there were prior clots following open-heart surgery, if medical care was sought following any of the events, if imaging of the brain (ct or mri) was performed to determine a cause, if there were any long-lasting deficits as a result of the tia events, if any details of each separate event could be provided, if there was any other medical history (anemia, lupus, apa, or clotting disorders), the reason for narrow therapeutic range, and if there were any concerns with regards to the coaguchek device during any these incidents.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: 15886046
• MDR Text Key: 304522075
• Report Number: 1823260-2022-03806
• 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: 11/30/2022

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: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/30/2022
• 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: ASPIRIN; ATORVASTATIN; BIMATOPROST; CARVEDILOL; CIRTALEN; LEVETIRACETAM; LEVOTHYROXINE; MECLIZINE; METFORMIN; OLMESARTAN; TORSEMIDE; WARFARIN
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 97 KG