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

Catalog Number 04625374160

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993); Non Reproducible Results (4029)

Patient Problems Ischemia Stroke (4418); Insufficient Information (4580)

Event Date 09/26/2021

Event Type  Injury  

Manufacturer Narrative

The customer's meter was requested for investigation.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.Occupation - the occupation is patient/consumer.

Event Description

It was alleged that a patient had a stroke on (b)(6) 2021.The patient was allegedly using coaguchek xs meter serial number (b)(4) at the time of the event.The patient's therapeutic range is reported to be 2.0 - 3.0 inr.It was not known if this was the therapeutic range on the date of the alleged event.The stroke was reported to be a blood clot in the patient's brain.It is not known what diagnostics were used to diagnose the stroke.It is not known if the patient's carotid artery was checked.The patient was reported to be in the intensive care unit of the hospital for 4 days and was hospitalized for one month.It is not known what the patient's inr laboratory results were while hospitalized.The meter inr results leading up to the stroke are not known.It is not known if any changes had been made to the patient's warfarin medication or if there were changes in the patient's lifestyle leading up to the stroke.It was reported that the patient was tested every other week leading up to the stroke and now tests weekly.It was reported that the patient was given medication at the hospital to break up the clot.It is not known if there was any other treatment provided to the patient.It was reported that the patient is currently stable and at home.The reporter was questioning whether the patient's memory may have been affected by the stroke.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

The customer's meter was returned for investigation where it was tested using retention test strips (lot 54145311, expiration date = 30-nov-2022) and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.5 inr.Qc 2: 5.3 inr.Qc 3: 5.5 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.It was reported that the patient does not test within 15 seconds of pricking their finger.When using capillary blood apply the sample to the test strip within 15 seconds after lancing the fingertip and within 30 seconds when using venous blood.The patient is taking lovenox.Per product labeling, the coaguchek xs pt test is insensitive to low molecular weight heparins (lmwh) up to 2 iu/ml antifactor xa activity.

Manufacturer Narrative

The device code 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
• 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: 15588992
• MDR Text Key: 301592928
• Report Number: 1823260-2022-03133
• 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,Followup,Followup
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2022
• 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: LOSARTAN.; LOVENOX.
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 116 KG