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

Catalog Number ASKU

Device Problems Insufficient Information (3190); Non Reproducible Results (4029)

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

Event Date 05/21/2021

Event Type  Injury  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi): asku.This case was reported by a pharmacist.Due to data protection reasons, the pharmacist would not provide the patient contact information and did not share further information regarding this event.Additional information and the product were requested for investigation.We have not received additional information regarding the event or patient and the product has not been received at this time.If the product or additional relevant information is received 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.The cause of the event and the contribution of the device to the alleged injury could not be determined based on the limited information provided.

Event Description

We received a report of questionable inr results with an unspecified coaguchek system with an unspecified serial number.The only information received from the reporter was that the patient suffered a stroke due to "incorrectly measured values" with the coaguchek device.The date of event was requested but was not provided.Prior inr results from the meter were requested but were not provided.Inr results from the meter and any laboratory results from the time of the event were requested but were not provided.Any comparison results between the meter and the laboratory were requested but were not provided.It is not known if the patient received any treatment.This information was requested but was not provided.It is not known if the patient was hospitalized.This information was requested but was not provided.Diagnostic testing results from the hospital were requested but were not provided.No specific patient information was provided.Medications, demographic information, therapeutic range, medical history and frequency of inr testing were requested but were not provided.The patient¿s current condition was requested but was not provided.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COAGUCHEK XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12008103
• MDR Text Key: 256450162
• Report Number: 1823260-2021-01747
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: ASKU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/21/2021
• Initial Date FDA Received: 06/16/2021
• Supplement Dates Manufacturer Received: 05/21/2021
• Supplement Dates FDA Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other