MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PT TEST PST; PROTHROMBIN TIME MONITOR

Catalog Number 07671687016

Device Problem High Test Results (2457)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 04/24/2023

Event Type  Injury  

Manufacturer Narrative

Occupation is patient/consumer.The meter and test strips were requested for investigation.No material was returned for the investigation.The patient was sent a different coaguchek inrange meter to perform comparison testing.The results from the patient¿s coaguchek inrange meter in question and the different coaguchek inrange meter were reportedly the same using 2 different strip lots.The specific results were not provided.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.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." the patient has antiphospholipid antibody syndrome.Product labeling states: "the presence of antiphospholipid 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.".

Event Description

We received an allegation that a patient was hospitalized for venous thrombosis while using coaguchek inrange meter serial number (b)(6).On (b)(6) 2023 the meter result was reportedly 3 inr.On (b)(6) 2023 the meter result was reportedly 3 inr.On (b)(6) 2023 the patient was reportedly hospitalized for venous thrombosis.The laboratory result at the hospital from an unknown method was reportedly 1.5 inr.On (b)(6) 2023 the meter result was reportedly 2.9 inr.Within 3 hours, the laboratory result from an unknown method was reportedly 1.5 inr.The specific details related to the patient's hospitalization (diagnostic tests, treatment received, and length of stay) were not provided.The patient¿s therapeutic range is reportedly 3 ¿ 4 inr.

• Brand Name: COAGUCHEK XS PT TEST PST
• Type of Device: PROTHROMBIN TIME MONITOR
• 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: 16977816
• MDR Text Key: 315705198
• Report Number: 1823260-2023-01709
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K170960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 07671687016
• Device Lot Number: 62215316
• Was Device Available for Evaluation?: No
• 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: WARFARIN
• Patient Outcome(s): Hospitalization
• Patient Sex: Male