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

Catalog Number 04625412003

Device Problem High Test Results (2457)

Patient Problem Insufficient Information (4580)

Event Date 01/10/2024

Event Type  Injury  

Manufacturer Narrative

Examples of additional information requested but not provided at this time include: additional meter results, to confirm recent stability of inr.Additional meter to laboratory comparison inr results.Any changes to the patient's therapy or medications following the first stroke.Any changes to the patient's diet or lifestyle that could potentially impact the inr.Additional medical conditions that are limitations of the coaguchek device such as anemia, antiphospholipid syndrome, and liver disease.The symptoms of the patient's stroke event and any long-term consequences.Any therapy that the patient received for the stroke event or low inr.The patient's strip lot number is 71519315 and the expiration date is 31-dec-2024.The meter and strips were requested for investigation.Replacement product was sent.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.

Event Description

We received an allegation that results from the coaguchek xs meter may have led to a patient's hospitalization for a stroke.It was reported that on (b)(6) 2024, the patient had a meter result of 2.4 or 2.5 inr and the patient's neurologists alleged that this led to the patient taking a lower marcumar dosage than needed.The patient's daughter reports that he had been on the same dosage without change for some time.No recent adjustments were made to the patient's marcumar dosage.It was reported that the patient experienced a stroke the same day and was admitted to the intensive care unit.On (b)(6) 2024, the patient reportedly had a laboratory result of 1.8 or 1.9 inr using an unknown method.The reporter alleged that parallel measurements were performed quarterly at the patient's cardiologist clinic.Reportedly, the comparison results were always good and therefore there was no reason to change the medication dose.The patient has reportedly always taken 1/4 tablet each day in recent months because his inr has been stable and around 2.4 -2.5 inr.The patient¿s therapeutic range is 2.0 - 2.5 inr.The patient's testing frequency is weekly, though it was reported that the patient tests 2-3 times a week following their stroke in (b)(6) 2023.

• Brand Name: COAGUCHEK XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18610406
• MDR Text Key: 334140121
• Report Number: 1823260-2024-00276
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): Y
• Reporter Country Code: AU
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/30/2024

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 Catalogue Number: 04625412003
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; ATORVASTATIN; CEDACORON; LASIX; MARCUMAR; RAMIPRIL
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male