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

Catalog Number 04625374160

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Non Reproducible Results (4029)

Patient Problem Thromboembolism (2654)

Event Date 05/16/2022

Event Type  Injury  

Manufacturer Narrative

The meter and strips have been requested for return.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and the 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." reporter occupation: was patient/consumer.

Event Description

The initial reporter alleged questionable results from coaguchek xs meter serial number (b)(4) and mentioned she was hospitalized for a clot in her eye.Around 9:30 am on (b)(6) 2022, the result from the reporter's meter was allegedly 2.9 inr.Later the same day, the reporter's vision allegedly went blurry, and then her right eye lost complete vision, but then came back partly.On the same day, the reporter went to the eye doctor and they reportedly used an eye machine to take a picture and allegedly found a clot in the eye.The eye doctor reportedly told her that the clot in her eye was essentially a stroke, and sent her to the hospital immediately.At the hospital, a stroke protocol was reportedly followed to check speech, and facial muscles, and then a ct with contrast was performed to check her brain and neck.Around 3:00 pm on (b)(6) 2022, the result from the hospital laboratory using an unknown reagent was reported to be 2.7 inr or 2.4 inr.The reporter was then allegedly admitted and kept at the hospital for a week for anticoagulation.On (b)(6) 2022 at 3:00 am, the result from the hospital laboratory using an unknown reagent was reported to be 2.0 inr.Allegedly, a regular echo was performed.The results of the echo were not provided.On (b)(6) 2022, allegedly a transesophogeal echocardiogram (tee) was performed that showed several small clots in the mitral valve.The reporter allegedly was kept on the same dose of coumadin and an agatriban drip was added.On (b)(6) 2022, the reporter was discharged.After leaving the hospital, the reporter was treated with arixtra injections from (b)(6) 2022 through (b)(6) 2022.The therapeutic range prior to clot was 2.5-3.5 inr.Afterward, the therapeutic range was allegedly changed to 3.5-4.5 inr.The reporter allegedly tests weekly.The reporter's current condition was provided as stable.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

Na.

• 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: 14786681
• MDR Text Key: 294595787
• Report Number: 1823260-2022-01821
• 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: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 04625374160
• Device Lot Number: 57790221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2022
• 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: COUMADIN.; LIPITOR.
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 86 KG