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

Catalog Number 04625412003

Device Problem High Test Results (2457)

Patient Problems Stroke/CVA (1770); Speech Disorder (4415); Unspecified Nervous System Problem (4426); Insufficient Information (4580)

Event Date 03/15/2021

Event Type  Injury  

Manufacturer Narrative

The meter and test strips were requested for investigation.Replacement product was sent.The product has not been received at this time and is not expected to be returned.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.The cause of the event and the contribution of the device to the alleged injury could not be determined based on the limited information provided.Product labeling states: "the coaguchek system uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas deviations can occur when compared to methods using other thromboplastins.However, those deviations between thromboplastins of different origin (e.G., rabbit based) are not specific to coaguchek products.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared to other laboratory methods." occupation - the occupation is the patient's wife.

Event Description

We received a letter alleging questionable inr results with a coaguchek xs meter that reportedly led to a stroke event.The coaguchek xs meter serial number was requested but not provided.It was reported that the patient was admitted to the hospital with an inr result of 1.7 inr.It is unclear from the limited information provided whether this result was from the meter or the hospital laboratory.The patient's therapeutic range was reportedly 2.5 inr- 3.5 inr.After the patient was released from the hospital, the patient was allegedly placed in rehabilitation for an unknown length of time.The initial reporter stated the patient "needs help in everyday life, can hardly speak and understand his mother's speech." examples of additional information requested but not provided at this time include: the patient's testing frequency.Whether there were any warfarin dosage changes prior to the event and if so based on which inr results.Whether there were any changes to the patient's therapeutic range in the course of the events.Duration of hospitalization, ward of hospitalization, diagnostics performed in hospital and findings, therapeutic approach and interventions performed in the hospital, therapeutic medication regimen introduced during hospitalization.Type of stroke event.This mdr is being submitted in an abundance of caution.

• Brand Name: COAGUCHEK XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• 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: 13722061
• MDR Text Key: 286942310
• Report Number: 1823260-2022-00645
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2022

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: 04625412003
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 03/10/2022
• 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: UNSPECIFIED ANTICOAGULATION
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Male