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

Catalog Number 04625374160

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Cognitive Changes (2551); Balance Problems (4401); Hemorrhagic Stroke (4417); Insufficient Information (4580)

Event Date 09/03/2021

Event Type  Injury  

Manufacturer Narrative

Occupation is a patient/consumer.The patient's meter and strips were requested for investigation.Only the patient's meter was provided for investigation where it was tested using retention strips and retention controls.Testing results (qc range = 2.5 - 3.7 inr): qc 1: 3.1 inr, qc 2: 3.0 inr, qc 3: 3.0 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.

Event Description

The reporter alleged that meter readings for one patient using the coaguchek xs pro meter serial number (b)(4) were varying from test to test.While troubleshooting the allegation, the reporter also mentioned that this patient had a stroke.The patient reportedly had a stroke on approximately (b)(6) 2021.The patient's inr was reportedly low at the time of the stroke.The type of stroke was requested but is unknown to the reporter.The most recent inr meter result prior to the (b)(6) 2021 was reportedly 3.0 inr on (b)(6) 2021 at 7:14 am.It was reportedly believed that no changes were made to the patient's warfarin dose prior to the stroke.The patient was reportedly treated for the stroke with an unknown concentration of heparin via iv (intravenous drip feed).Per product labeling, "testing has confirmed that pt/inr test results are not affected by heparin concentrations up to 0.8 u/ml [or] low molecular weight heparins (lmwh) up to 2 iu anti-factor xa activity/ml." it was reported that the patient's therapeutic range is 2.5 - 3.5 inr and tests 2-3 times a week.There were reportedly no meter to laboratory inr comparisons performed on the meter.The reporter declined to answer any further questions related to these events.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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13290832
• MDR Text Key: 284031274
• Report Number: 1823260-2022-00160
• 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: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 54145321
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2021
• 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: LEVOTHYROXINE; MULTAQ; UNSPECIFIED BLOOD PRESSURE MEDICATION; UNSPECIFIED MULTIVITAMIN; UNSPECIFIED STATIN FOR CHOLESTEROL; WARFARIN
• Patient Outcome(s): Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 47 KG