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 04/27/2018

Event Type  Injury  

Manufacturer Narrative

The reporter's meter and 2 vials of test strips were provided for investigation where they were tested using retention controls.Vial #1 testing results (qc range = 2.3 - 3.5 inr): qc 1: 2.9 inr, qc 2: 2.9 inr, qc 3: 2.9 inr.Vial #2 testing results (qc range = 2.3 - 3.5 inr): qc 1: 2.9 inr, qc 2: 2.9 inr, qc 3: 2.9 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The customer stated that they do not know if they test within 15 seconds of pricking their finger.Product labeling states: "after sticking your finger, you have 15 seconds to apply blood to the test strip.If it takes longer to form a good drop of blood, lance a different finger for the test." 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 method uses human recombinant thromboplastin.Therefore, the comparability to tests using other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastin types.However, those higher differences between thromboplastins of different (rabbit, bovine) origin are not an issue specific for coaguchek assays.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared with several other (rabbit, bovine) laboratory methods." the investigation did not identify a product problem.The cause of the events could not be determined.Occupation is patient/consumer.

Event Description

The reporter called alleging receiving questionable results from the coaguchek xs meter with serial number (b)(4).On the call, the reporter also mentioned the occurrence of four "mini-stroke" events.The reporter stated that she estimates that all strokes occurred in the last 4 - 5 years.For the first three "mini-strokes", the patient reportedly lost partial to complete sight in her left eye for less than a minute.She further stated that for the first two "mini-strokes", she did not require medical treatment as she was reportedly unaware that they were strokes and reportedly did not take any actions based on the brief loss of her sight.The reporter did not provide dates for the first two "mini-strokes" and provided no information regarding inr results either before or after these first two events.On (b)(6) 2020, the patient reportedly had her third "mini-stroke".She reportedly contacted her doctor who advised her to go into the office.She stated that they were able to determine she had experienced "mini-strokes" after the third occurrence when she saw her eye doctor.The eye doctor was able to reportedly determine that she had suffered a transient ischemic attack.The reporter stated that no medical treatment was provided for this "mini-stroke" and she provided no information regarding inr results either before or after this (b)(6) 2020 "mini-stroke".On (b)(6) 2022, the reporter stated that a fourth "mini-stroke" occurred.She reportedly lost partial sight, this time to her right eye for approximately 1 minute.She stated that she did not take any action based on this occurrence and did not contact her doctor until the day she reported her meter result of 3.2 inr on (b)(6) 2022.The reporter confirmed that there was no permanent impairment or permanent damage to a body function or structure.Allegedly, there were no medical or surgical interventions required due to these incidents.The therapeutic range is 3.0-3.5 inr and testing is performed weekly.This mdr is being submitted in an abundance of caution.

• 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: 14496252
• MDR Text Key: 292609566
• Report Number: 1823260-2022-01477
• 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
• Report Date: 05/25/2022

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: 56561322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/25/2022
• 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: AMOXICILLIN (IF DENTAL WORK IS REQUIRED); ARIPIPRAZOLE; ATENOLOL; B12; BABY ASPIRIN; CENTRUM SILVER; CITRACAL CALCIUM TABLETS; CYCLOBENZAPRINE (AS NEEDED); DULOXETINE; EZETIMIBE; FAMOTIDINE; FISH OIL + OMEGA 3; JANTOVEN; LAMOTRIGINE ODT; LISINOPRIL; MAGNESIUM; PRALUENT; VITAMIN C; VITAMIN D3; ZAFIRLUKAST
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 88 KG