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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problem Coagulation Disorder (1779)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

Occupation is lay user/patient the meter and test strips were 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.Test strip retention samples passed the internal inspection.Product labeling states: "the coaguchek system uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas deviations can occur when compared to methods using other thromboplastins.However, those deviations between thromboplastins of different origin (e.G., rabbit based) are not specific to coaguchek products.Similar differences can be observed when a human recombinant thromboplastin based laboratory method is compared to other laboratory methods." the currently provided information does not reasonably suggest that the use of coaguchek meter caused the alleged event.

Event Description

The initial reporter questioned inr results from coaguchek xs meter serial number (b)(4).The reporter alleged the results from the device contributed to a stroke.The result from the meter at 5:30 p.M.Was 2.6 inr.Approximately 2.5 hours later, the customer¿s face started to feel numb and she lost feeling in her right hand.At 9:30 p.M.The result from the laboratory using an unknown method was 1.0 inr.The customer¿s therapeutic range is 2.5 ¿ 3.5 inr.At the hospital, the customer¿s coumadin dose was increased to 6 mg and she was put on a heparin drip.The customer stated one side of her face is still numb and she continues to experience loss of feeling in her right hand.It is not known how long the customer was in the hospital.The customer declined to provide any inr results she received prior to the event.She declined to provide any information related to possible changes in coumadin, diet or other medications prior to the event.The customer declined to provide the results from any diagnostic tests that were performed to diagnose the stroke.The customer also alleged the results from the meter contributed to strokes in jul-2020 and sep-2020.She did not receive treatment for one of the strokes that occurred in july or september; she went to the hospital for the other one.The customer declined to provide any information related to this hospitalization.No inr results were provided related to either event in jul-2020 or sep-2020.

Manufacturer Narrative

Question 1: is there any evidence (e.G.Imaging) to confirm the patient¿s stroke diagnosis? question 2: is the stroke hemorrhagic or ischemic? answer: during the initial call, the customer declined to continue troubleshooting and declined to provide patient information.In an attempt to answer the above questions three additional attempts were made to contact the customer and voice mail messages were left.To date, the customer has not returned our calls.At this time we cannot answer the above questions.If the customer returns our calls we will provide the additional information through the supplemental process.

Manufacturer Narrative

The customer's meter and test strips were provided for investigation where they were tested using lin 3 controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.1 inr.Qc 2: 5.2 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The result of 2.6 inr alleged by the customer was observed in the meter¿s patient result memory, but the time/date was set incorrectly.The investigation did not identify a product problem.

• 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: 11108733
• MDR Text Key: 224810275
• Report Number: 1823260-2021-00009
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 49016921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 12/07/2020; 12/07/2020
• Supplement Dates FDA Received: 01/20/2021; 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN.; COUMADIN
• Patient Outcome(s): Hospitalization