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); Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Insufficient Information (4580)

Event Date 06/01/2022

Event Type  Injury  

Event Description

We received an allegation that a patient had a stroke while coaguchek xs meter serial number (b)(6) was in use.The initial reporter called for assistance on how to set the date and time on the meter.During the call, a stroke event was alleged.The stroke reportedly occurred "around (b)(6) 2022." the patient reportedly went to the hospital but the initial reporter could not recall any further information.Examples of additional information requested but not provided at this time include: meter results prior to the event.Whether any dosage changes were made based on meter results prior to the event.Diagnostic testing that was performed and the results from those tests.Inr results from the hospital.Whether the stroke was ischemic or hemorrhagic.The symptoms of the stroke that prompted the patient to go to the hospital.If the patient received any treatment for inr.If the patient had any bleeding issues or if the patient was treated with any blood products.What therapy the patient was given at the hospital the patient¿s therapeutic range is reportedly 2.5 ¿ 3.5 inr with an alleged testing frequency of once a week.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

Occupation is patient/consumer the product 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.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.

Manufacturer Narrative

The device code was 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: 16994237
• MDR Text Key: 315865742
• Report Number: 1823260-2023-01730
• 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
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• 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: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2023
• 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
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 78 KG