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 09/15/2022

Event Type  Injury  

Event Description

We received an allegation that the coaguchek xs meter with serial number: (b)(4) may have contributed to the patient's alleged hospitalization due to a blood clot.The patient stated that he went to the doctor for a cardiogram on (b)(6) 2022.The patient stated that the doctor found a blood clot and that the mitral valve was reportedly deteriorated.He was then reportedly admitted to the hospital on the same day.The patient stated that the laboratory result upon admission was 1.9 inr.The patient was reportedly given heparin therapy while in the hospital and a scope was also reportedly put down his throat to look at the mitral valve.The patient stated that he also received another cardiogram and some x-rays.The patient stated that the blood clot was dissolved and that he is unsure what caused the blood clot.On (b)(6) 2022, at 3:00 pm, the laboratory result using an unknown laboratory method, was 2.5 inr.The meter result at 5:00 pm was 5.5 inr.The patient stated that he was released from the hospital on (b)(6) 2022.The patient stated that he received the meter a month prior to being hospitalized.The patient stated that his warfarin dose was adjusted accordingly.The therapeutic range is 2.5-3.5 inr.The interval of testing is 1x per week.

Manufacturer Narrative

The reporter's meter and test strips were provided for investigation where they were tested using retention controls.Testing results (qc range = 2.4 - 3.6 inr): qc 1: 3.0 inr.Qc 2: 3.0 inr.Qc 3: 3.1 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 results alleged by the customer were observed in the meter¿s patient result memory.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 patient stated that he has antiphospholipid antibodies (apa).Product labeling states "the presence of anti-phospholipid antibodies (apas) such as lupus antibodies (la) may lead to prolonged clotting times, i.E., they may cause false-high inr values.If you have or suspect that you have apas, discontinue testing until you discuss with your physician." occupation: patient/consumer.

• 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: 15681061
• MDR Text Key: 302496653
• Report Number: 1823260-2022-03375
• 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: K062925
• 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: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 04625374160
• Device Lot Number: 60124921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Date Manufacturer Received: 09/27/2022
• 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: "IVIG" EVERY MONTH (FOR IMMUNE SYSTEM); AFROZOL; ASPIRIN; ATORVASTATIN; B12 VITAMIN; CARDIZEM; CITALOPRAM; LASIX; METOPROLOL; POTASSIUM; PREDNISONE; TRAZADONE; TRELEGY; WARFARIN
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 107 KG