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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problem Thromboembolism (2654)

Event Date 08/11/2021

Event Type  Injury  

Manufacturer Narrative

The customer's meter was requested for investigation and replacement product was sent to the customer.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.The reporter's meter and test strips were provided for investigation where they were tested using retention controls.Testing results (qc range = 2.1 - 3.3 inr): qc 1: 3.0 inr, qc 2: 2.9 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.The maximum difference between measurements was 3%.Per product labeling: "coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods." initial reporter occupation - the occupation is lay user/patient's husband.

Event Description

The initial reporter called asking for help in calibrating coaguchek xs meter serial number (b)(4) and then stated a patient allegedly received questionable results and reportedly had a blood clot when using the meter.At 14:19 on (b)(6) 2021, the patient had a meter result of 2.9 inr.At 10:55 on (b)(6) 2021, the patient had a meter result of 3.7 inr.At 11:54 on (b)(6) 2021, the patient had a meter result of 2.6 inr.The patient's therapeutic range was 2.0 - 3.0.On (b)(6) 2021, the patient's husband drove the patient to the emergency room for pain in the right leg.The patient waited for 36 hours to get a room and to be admitted as the hospital was overcrowded.The patient was only treated with pain medication for her leg.The patient had no meter to laboratory comparison measurements prior to hospitalization.On approximately (b)(6) 2021, an ultrasound and a venous study were performed on the patient.The result showed that the patient had good flow.The patient was transferred to another hospital on (b)(6) 2021 as the first hospital did not have the equipment to run further tests.On (b)(6) 2021, a computer-aided tomography (cat) scan was performed on the patient and a clot/occlusion was found behind the knee.The patient had surgery to remove the clot on (b)(6) 2021.On (b)(6) 2021, the patient's therapeutic range was changed to 2.5 - 3.0 inr.The patient's testing frequency is once per week.At 18:45 on (b)(6) 2021, a sample from the patient was tested using the meter, resulting in a value of 4.5 inr.Within minutes of meter testing, a sample from the patient was tested in the laboratory using an unknown method, resulting in a value of 3.3 inr.At 14:01 on (b)(6) 2021, a sample from the patient was tested using the meter, resulting in a value of 4.4 inr.At the same time, a sample from the patient was tested in the laboratory using an unknown method, resulting in a value of 1.7 inr.

Manufacturer Narrative

For the atrial fibrillation of the patient on (b)(6) 2021, no ultrasound was performed on the patient.The patient had both an angiogram and echocardiogram.The patient's therapeutic range was increased on (b)(6) 2021 because of the patient's clot history and to try to dissolve the patient's remaining clots.The patient's husband mentioned that the patient is no longer on warfarin therapy and is not testing on any meter.The patient is taking lovenox treatment only due to her kidney cancer treatments.

• 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: 12555837
• MDR Text Key: 274324144
• Report Number: 1823260-2021-02862
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• 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
• Report Date: 10/06/2021

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 Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 09/30/2021
• Supplement Dates Manufacturer Received: 10/06/2021
• Supplement Dates FDA Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; ENOXAPARIN( AS NEEDED); LEVOTHYROXINE; LEXAPRO; METOPROLOL; MULTAQ; ROSUVASTATIN; TORSEMIDE; WARFARIN
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Weight: 66