MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK VANTUS; PROTHROMBIN TIME MONITOR

Model Number COAGUCHEK INRANGE

Device Problems Circuit Failure (1089); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 05/08/2022

Event Type  Injury  

Event Description

There was an allegation of coaguchek vantus meter error messages that prohibited the patient from being able to perform inr tests.Reportedly the patient had a clot in her neck and is in the hospital.The reporter alleged they had a measurement of 3.8 inr on (b)(6) 2022.The returned meter memory confirmed a measurement of 3.8 inr on (b)(6) 2022 at 04:25 a.M.The patient's warfarin dosage was decreased by 1 mg.The test strip lot number was 56561321 with an expiration date of 31-may-2023.After the reading of 3.8 inr, additional attempts were allegedly made to test on (b)(6) 2022 and it was reported the coaguchek vantus meter showed an m-31 message.The reporter confirmed the battery compartment was clean and dry.For message m-31, product labeling states, "batteries empty: batteries are nearly empty.Replace batteries now." reportedly the meter's batteries were replaced and the battery contacts were cleaned, but the issue persisted.The reporter stated the meter's batteries were replaced again but the meter displayed an error message e-63.For e-63, product labeling states, "meter error: hardware or electronic error.Power meter off and on.If error persists, contact roche diagnostics." (b)(6) 2022 was believed to be the last time the patient attempted to use the meter.On (b)(6) 2022, allegedly the patient's hands and feet began to swell.On (b)(6) 2022, it was reported the patient was advised by her physician to go to the emergency room (er).Allegedly the patient went to the er and a clot was discovered in the patient's neck.The reporter "thinks" the left ventricular was blocked and "believes" the hospital inr result was in the "1.0's" when admitted.Reportedly the patient was taken off warfarin and was administered a heparin drip intravenously (iv).It was reported that "they do not know what caused the clot to form." reportedly the patient did not suffer a stroke and did not require surgery.The type of tests performed on the patient is unknown.Reportedly "the blood clot has dissolved and the patient is still currently in the hospital." allegedly the patient will be discharged once the inr levels reach the therapeutic range and she will be sent home with lovenox injections.The patient's therapeutic range was 2.5-3.0 inr.The patient's testing frequency is weekly.

Manufacturer Narrative

The reporter's meter and test strips were provided for investigation where they were tested using retention controls.Replacement product was sent.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.0 inr.Qc 2: 5.0 inr.Qc 3: 4.9 inr.The error messages, m-31 and e-63, were resolved with the use of retention batteries during the investigation.The meter was able to be successfully tested and no error messages occurred during the investigation.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.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 investigation did not identify a product problem.The cause of the event could not be determined.Occupation is patient's daughter/consumer.

• Brand Name: COAGUCHEK VANTUS
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14648686
• MDR Text Key: 294886279
• Report Number: 1823260-2022-01680
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702700499
• UDI-Public: 00365702700499
• 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: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: COAGUCHEK INRANGE
• Device Catalogue Number: 07729952160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Date Manufacturer Received: 05/12/2022
• 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: AMLODIPINE; ATORVASTATIN; DOCUSATE SODIUM; FAMOTIDINE; LOSARTAN; METHOTREXATE; METOPROLOL; TRAMADOL; TYLENOL; VITAMIN D2; WARFARIN
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 59 KG