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

Catalog Number 04625374160

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 05/12/2021

Event Type  Injury  

Manufacturer Narrative

The customer's meter and test strips were requested for investigation and replacement product was sent to the customer.Test strip retention samples passed the internal inspection.The customer's meter and one remaining test strips were provided for investigation where they were tested using retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.3 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.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.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." medwatch field udi number = (b)(4).Medwatch field occupation - the occupation is lay user/patient.For patient code "appropriate clinical signs, symptoms, conditions term / code not available", the appropriate coding would be "thrombosis/thrombus" and "therapeutic response increased".

Event Description

It was reported that accuracy of coaguchek xs meter serial number (b)(4) was questioned after blood clots were detected in a patient on (b)(6) 2021 prior to a planned cardioversion procedure.On (b)(6) 2021 at 7:26 a.M., a sample from the patient was tested using the meter, resulting in a value of 2.1 inr.The patient was kept on the same normal warfarin dose of 2.5 mg.That day and 5 mg.Every other day.At this time, the patient's therapeutic range was 2.0 - 3.0 inr.On (b)(6) 2021, the patient was at the hospital for cardioversion.At the hospital, a fingerstick sample and venous sample were collected from the patient at the same time.The fingerstick sample was tested on an unknown device, resulting in a value of 1.4 inr.The venous sample was run in the laboratory using an unknown method, resulting in a value of 1.7 inr.A cardioversion was not performed on the patient.The patient received a transesophageal echocardiogram (tee) and this revealed clots in the upper left atrium of the patient's heart.It is not known if the clots were in more than one heart chamber.Based on the tee findings and inr results from (b)(6) 2021, the patient's warfarin dosage was increased and lovenox was added to the patient's regimen.Warfarin dosage was increased to 7.5 mg.On mondays and thursdays and then 5 mg.Every other day of the week.Lovenox medication was started on (b)(6) 2021.The patient was not admitted to the hospital.After the event, the patient's therapeutic range was updated to 2.5 - 3.5 inr.The patient's testing frequency is weekly.

Manufacturer Narrative

The reporter's meter was also tested with retention strips and retention controls.Testing results with retention strips (qc range = 4.1 - 6.8): qc 1: 5.5 inr, qc 2: 5.5 inr, qc 3: 5.3 inr.The maximum difference between measurements was 4%.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.

• 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: 11939475
• MDR Text Key: 254434537
• Report Number: 1823260-2021-01658
• 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
• Report Date: 07/07/2021

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 Expiration Date: 03/31/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 49682021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Initial Date Manufacturer Received: 05/13/2021
• Initial Date FDA Received: 06/04/2021
• Supplement Dates Manufacturer Received: 05/13/2021
• Supplement Dates FDA Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVAIR; ALBUTEROL (AS NEEDED); ALVESCO; CLARITIN; CO-Q10; CRANBERRY PILL; FISH OIL; IPRATOPRIUM BROMIDE NASAL SPRAY; LEVOTHYROXINE; LIPITOR; LISINOPRIL; MAGNESIUM OXIDE; MIRALAX; NOVAGE; PREDNISONE (AS NEEDED); PROBIOTIC; SINGULAIR; SOTALOL; TESLON PEARLS (AS NEEDED); TORSAMIDE; TURMERIC; VITAMIN C; VITAMIN D; WARFARIN
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 60