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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problem Transient Ischemic Attack (2109)

Event Date 11/22/2021

Event Type  Injury  

Manufacturer Narrative

The test strips used on the date of the event were unavailable for return.The meter and test strips were provided for investigation where they were tested using retention controls.The test strips returned were lot number 52818122.Replacement product was sent.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.4 inr, qc 2: 5.4 inr, qc 3: 5.5 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.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 investigation did not identify a product problem.The cause of the event could not be determined.Occupation is patient/consumer.

Event Description

While troubleshooting it was mentioned that 1 patient had a transient ischemic attack (tia) while using a coaguchek vantus meter serial number (b)(4).On (b)(6) 2021 and "around 3 p.M.," it was reported the patient became disoriented, confused, agitated, and started slurring words.The patient's wife reportedly called 911 and the patient was transported to the hospital by ambulance.When the patient arrived at the hospital, allegedly the patient's inr result by laboratory draw was 1.79 inr.The patient was reportedly admitted to the hospital from 22-nov-2021 to 24-nov-2021.On (b)(6) 2021, the patient's laboratory inr result was reportedly 1.64 inr.On (b)(6) 2021, the patient's laboratory inr result was reportedly 1.71 inr.All of the hospital inr measurements were done by bedside venous samples.It was reported the patient had a computed tomography (ct) scan on the brain and there was evidence of a clot.Due to the findings, the patient allegedly had an (mri) magnetic resonance imaging performed on the brain.Reportedly the mri did not show any findings of a clot or damage.Allegedly the patient was provided ativan by intravenous (iv) for agitation.It was reported the patient "believes" there were adjustments to his warfarin dose but the adjustments were unknown.It was reported the patient received no other treatments.It was reported the cause of the tia was unknown.It was reported the patient's current condition was "feels good." the patient's therapeutic range was 3.0-3.5 inr.The patient's testing frequency was reported as "every two weeks but currently testing weekly due to inr being out of range.".

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14310131
• MDR Text Key: 292984311
• Report Number: 1823260-2022-01298
• 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: 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: 05/05/2022

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: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 05/06/2022
• 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: ASPIRIN 81MG; ATORVASTATIN; CARVEDILOL; CORTISONE SHOT; CREON; FINASTERIDE; GABAPENTIN; IRON; KIRKLAND BRAND FISH OIL 1000MG; LISINOPRIL; MEMBER'S MARK ADULT 50+ MULTIVITAMIN; METFORMIN; OMEPRAZOLE; OXYCONTIN; PERCOCET; TAMSULOSIN; TRAMADOL; TURMERIC SUPPLEMENT; TYLENOL; VITAMIN D3 50MCG; WARFARIN
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 62 KG