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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 04/20/2023

Event Type  Injury  

Manufacturer Narrative

The test strips were requested for investigation and have not been received at this time.If the product is returned in the future, a follow-up report will be submitted.  the reporter's meter was provided for investigation where it was tested using retention strips and retention controls.Testing results (qc range = 2.3 - 3.5 inr): qc 1: 2.9 inr.Qc 2: 2.8 inr.Qc 3: 2.9 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 the results have passed the internal inspection.  per product labeling: "coaguchek method uses human recombinant thromboplastin.Therefore, the comparability to tests using other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastin types.However, those higher differences between thromboplastins of different (rabbit, bovine) origin are not an issue specific for coaguchek assays.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared with several other (rabbit, bovine) laboratory methods the investigation did not identify a product problem.The cause of the event could not be determined.  section e3 - occupation: patient/consumer h3 other text : na.

Event Description

We received an allegation of a questionable inr result for one patient tested with the coaguchek vantus serial number with serial number (b)(6) compared to an unknown laboratory method and that this meter may have contributed to a patient's blood clots in the heart.The reporter stated that his doctor advised him to go to the laboratory because he believes the meter readings were incorrect.The reporter stated on (b)(6) 2023, his doctor discovered blood clots in his heart while performing an ablation procedure.The reporter stated that the doctor stopped the procedure and will reschedule the procedure after the clots are dissolved with warfarin therapy.The reporter stated that the doctor said that the blood clots in his heart were due to his atrial fibrillation (a-fib) and atrial (a) flutter.The reporter stated that he is going to have a transesophageal echocardiogram procedure in 4 weeks to see if he still has the blood clots in his heart and needs his inr to be within the therapeutic range for the procedure.The meter result was 3.2 inr.The laboratory result using a venous sample was 1.9 inr. the reporter stated that he performed the meter test 15 minutes before going to the laboratory.The reporter stated that his doctor advised him to decrease his warfarin to.5 mg for 2 days.The patient's therapeutic range was reported to be 3.0-3.5 inr.    this mdr is being submitted with 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17007582
• MDR Text Key: 315998360
• Report Number: 1823260-2023-01754
• 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: K170960
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: 64708121
• Date Manufacturer Received: 04/25/2023
• 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
• Treatment: METOPROLOL.; WARFARIN.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 116 KG