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

Catalog Number 07797826160

Device Problem High Test Results (2457)

Patient Problems Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 05/24/2021

Event Type  Injury  

Manufacturer Narrative

The meter and test strips were requested for investigation.The test strips are not available to 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 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." date of event is approximate as the exact date of the event was not provided.

Event Description

The initial reporter, a nurse treating the patient, alleged that incorrect meter readings from the coaguchek xs meter serial number (b)(4) led to a patient having a small deep vein thrombosis (dvt) in his leg.The nurse alleged meter readings gave higher results when compared to the laboratory.The nurse did not perform the testing or observe the meter readings and could not provide any dates/times but estimated the meter results were around 6.0 inr and the laboratory results were around 1.2 inr and all testing was performed at the same time.Upon gathering further information, the nurse advised the patient¿s meter results were 4.0 inr or higher and the laboratory results were around 1.6 inr on the same day at the same time.The nurse advised the patient¿s warfarin dose was based on the meter results, because it took several days to obtain the lab result.The nurse advised the patient complained of lower leg pain and swelling.When redness was noticed they sent him to his doctor and a small dvt in his lower leg was confirmed.The nurse stated she believes the patient's normal warfarin dose was 5mg for 3 days and either 2.5 or 2.0 mg the rest of the days but is not certain.The nurse is not sure how the dose was changed and thinks it was maybe held for a day or two based on the meter readings.The patient¿s therapeutic range is 2.0-3.0 inr.The frequency of testing was requested but not provided.Examples of additional information requested include: the patient's current condition.The exact date of the event.If the patient has been hospitalized.What kind of treatment the patient received at the hospital.The inr results on the meter within 2 weeks before the event.Where the clot in his leg came from (e.G.Heart.).The patient's other medical history (e.G.Special conditions.).The patient's other medications.If the patient takes a multivitamin including vitamin k.To date, this information has not been provided.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

No product is expected to be returned related to this case.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COAGUCHEK XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12436340
• MDR Text Key: 270214333
• Report Number: 1823260-2021-02623
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630946471
• UDI-Public: 04015630946471
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07797826160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WARFARIN; WARFARIN
• Patient Outcome(s): Other