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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problems Thromboembolism (2654); Insufficient Information (4580)

Event Date 11/01/2021

Event Type  Injury  

Manufacturer Narrative

The meter and test strips were requested for investigation and have 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 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.".

Event Description

The initial reporter questioned the accuracy of inr results that were allegedly within the therapeutic range for a patient from a coaguchek xs meter with an unknown serial number after the patient allegedly had a clot at the time of a heart valve replacement procedure.The patient allegedly had a clot in (b)(6) 2021, at the time of a heart valve replacement procedure.The exact date of the event in (b)(6) was not provided.The meter results were reportedly between 2.5-3.5 inr but the laboratory results were alleged to be consistently lower by 0.5 inr or 0.6 inr.The patient's medication was reportedly not adjusted based on the meter results.The therapeutic range was reported to be 2.5 - 3.5 inr.Multiple attempts were made to gather additional information regarding the patient and to date, further information has not been provided.Examples of information requested include: the patient's current condition.The type of anticoagulant the patient is taking.The patient's medical history.The patient's other medications.The patient's interval of inr testing.If the patient was under heparin when they performed the meter to laboratory comparisons.The localization of the reported clot in the heart valve.The indication for anticoagulation before the clot and procedure in (b)(6) 2021.If the anticoagulant's dosage was ever adjusted based on the meter results or only by the blood clot event in (b)(6) 2021.If the patient is taking multivitamins including vitamin k.The diagnostic procedures performed for the blood clot event in (b)(6) 2021.Treatment given for the blood clot.

Manufacturer Narrative

Medwatch field d10 was updated.

• 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: 13583857
• MDR Text Key: 290679894
• Report Number: 1823260-2022-00488
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• 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: VITAMIN K THROUGH PEDIASURE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 9 YR
• Patient Sex: Female