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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problem Coagulation Disorder (1779)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

The reporter's test strips were provided for investigation where they were tested using a retention meter and retention controls.Testing results with vial #1 (qc range = 2.3 - 3.5 inr): qc 1: 2.7 inr, qc 2: 2.8 inr, qc 3: 2.7 inr.Testing results with vial #2 (qc range = 2.3 - 3.5 inr): qc 1: 2.5 inr, qc 2: 2.8 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.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 customer stated they have apa syndrome.Per product labeling, this may cause false-high inr values and false-low quick values.Where apa is known to be present, it is imperative that a result be obtained using an apa-insensitive laboratory method for comparison.Occupation was lay user/patient.

Event Description

The initial reporter alleged he received questionable results from coaguchek xs meter serial number (b)(4) and alleged he had a stroke due to an incorrect meter result.The meter was set to an incorrect date for the following results: on "(b)(6) 2020", the meter result was 3.2 inr.On "(b)(6) 2020", the meter result was 2.6 inr.The correct date for this result was (b)(6) 2020 at 07:01 am.On (b)(6) 2020, the customer stated his left arm and left leg gave out and an ambulance was called to transport the customer to the hospital.The laboratory result using an unknown reagent at 7:00 pm was 1.1 inr.An mri and ct scan of the brain showed a stroke ("visible clot was in brain").Examination of the carotid artery: completely occluded.The customer did not get tiaa but was put on a heparin drip.The warfarin dose was not changed.Additional information was requested but the customer was not willing to answer any additional questions.The customer stated he was currently "feeling okay".The customer stated he was diagnosed with lupus at (b)(6) years old but was not sure if has lupus antibodies.Per product labeling, "the presence of antiphospholipid antibodies (apas) such as lupus antibodies (la) can potentially lead to prolonged clotting times, i.E., they may cause false high inr values.If you have or suspect that you have apas, contact your doctor and do not continue inr testing with this device." the customer stated he was anemic, but the actual hematocrit was unknown.Per product labeling, "hematocrit ranges between 25-55% do not significantly affect results." generally, in the case of anemia / severe anemia, you should not take anticoagulation dosage decisions based on meter results.The therapeutic range was 2.5-3.5 inr and the customer tests once a week.

• 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: 10901405
• MDR Text Key: 218219452
• Report Number: 1823260-2020-03011
• Device Sequence Number: 1
• Product Code: GJS
• 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: 11/24/2020

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 Expiration Date: 04/30/2021
• Device Catalogue Number: 04625374160
• Device Lot Number: 43002022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/25/2020
• 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: LIPITOR.; METOPROLOL.; WARFARIN.
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 77