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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problem Thromboembolism (2654)

Event Date 09/08/2021

Event Type  Injury  

Manufacturer Narrative

Occupation is patient/consumer.The meter and test strips were requested for investigation; however, the test strips in use at the time of the blood clots are no longer available.The meter and test strips from the time of the comparisons in (b)(6) and (b)(6) 2022 (lot 54974523) were provided for investigation where they were tested using retention controls.Testing results (qc range = 2.4 - 3.6 inr): qc 1: 2.9 inr, qc 2: 3.0 inr, and qc 3: 3.0 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 results alleged by the customer were observed in the meter¿s patient result memory.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and 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." the investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

On 17-feb-2022 we received an allegation that coaguchek xs meter serial number (b)(4) using strip lot 54974523 with expiration date 31-jan-2023 was not reading correctly when compared to an unknown laboratory method in (b)(6) 2022 and (b)(6) 2022.It was reported that the patient's therapeutic range used to be 2.5 - 3.5 inr but due to blood clots allegedly occurring in (b)(6) 2021 and (b)(6) 2021, the patient's therapeutic range was reportedly increased to 3.0 - 3.5 inr.The first alleged blood clot was identified on 08-sep-2021 and the second alleged blood clot was identified on 04-oct-2021.The test strip lot number used in (b)(6) 2021 and (b)(6) 2021 was not known.This medwatch will cover the first alleged blood clot identified on (b)(6) 2021.Refer to medwatch with patient identifier (b)(6) for information on the second alleged blood clot identified on 08-sep-2021 and medwatch with patient identifier (b)(6) for the meter to lab comparison results from (b)(6) 2022 and (b)(6) 2022.The meter results prior to the blood clot on 08-sep-2021 were: on 04-aug-2021: 3.1 inr, on 11-aug-2021: 2.7 inr, on 18-aug-2021: 2.8 inr, on 25-aug-2021: 3.3 inr, and on 01-sep-2021: 3.4 inr.On 08-sep-2021 the meter result was reportedly 6.1 inr.The patient allegedly went to the hospital due to pain in her side and a blood clot was allegedly identified in her spleen by ct scan.The patient¿s spleen was reportedly damaged and is allegedly still damaged but does not cause the patient any problems.No inr laboratory results are available from 08-sep-2021.On 09-sep-2021 the result from the hospital laboratory was reportedly 3.3 inr.The patient was reportedly in the hospital for 4-5 days.She was reportedly put on plavix in addition to warfarin.The doctors did not determine what caused the blood clot.Blood work was allegedly performed in an attempt to "find something genetic" but the patient does not think anything was found.The patient reportedly had a transesophageal echo (tee) scope performed to ensure her mechanical mitral valve was working correctly and they allegedly saw "some shadowing" at this time.The patient reportedly believes this shadowing was the second clot that would be identified on 04-oct-2021.On 10-sep-2021 the hospital laboratory results were reportedly 2.7 inr and 2.8 inr.No tests were performed on the meter.On 11-sep-2021 the hospital laboratory result was reportedly 3.3 inr.On 12-sep-2021 the hospital laboratory result was reportedly 4.1 inr.On 13-sep-2021 the hospital laboratory result was reportedly 3.5 inr.On 14-sep-2021 the hospital laboratory result was reportedly 2.5 inr.The patient's warfarin dose is reportedly based on the meter results unless there is a lab result available from the same day.If a lab result is available from the same day, the patient's warfarin dose is reportedly adjusted based on the laboratory results.The patient could not remember what specific adjustments were made prior to the blood clot in (b)(6) 2021.The patient reportedly used to test once per week, but, has "had to test more frequently at times due to the issues she has had.".

• 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: 13804417
• MDR Text Key: 292487407
• Report Number: 1823260-2022-00745
• 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: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• 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
• Date Manufacturer Received: 02/17/2022
• 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; CLOPIDOGREL/PLAVIX; CYCLOBENZAPRINE; DELOXITINE/CYMBALTA; LEVOTHYROXINE; VITAMIN D; WARFARIN
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 109 KG