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

Catalog Number 07797826160

Device Problems Improper or Incorrect Procedure or Method (2017); High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2022

Event Type  malfunction  

Event Description

We received an allegation of questionable inr results for one patient tested with a coaguchek xs meter serial number (b)(4) compared to an unknown laboratory methodology.For meter testing, the nurse wiped away the patient's first drop of blood and used the second drop for sample collection.Also, a different finger was used for each meter result the patient's meter results were ">8.0" inr and ">8.0" inr.The patient's laboratory result was 5.8 inr.All tests were completed within 30 minutes.The patient's dose was withheld based on the laboratory result.The patient's therapeutic range was 2.5-3.5 inr.The patient's testing frequency is weekly.

Manufacturer Narrative

The 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.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." also, product labeling states: "the action of oral anticoagulants (coumarin derivatives) can be increased or weakened when other medication is taken simultaneously (e.G.Antibiotics, but also prescription-free medication like pain relievers, antirheumatic medication and medication against influenza).This, in turn, can also lead to either an increase or a decrease in prothrombin time (inr).Additional medication should only be taken if prescribed by the treating physician.If other medication is taken, it is recommended that the prothrombin time be checked more frequently and that the anticoagulant dose be subsequently adjusted as directed by the treating physician.".

Manufacturer Narrative

The test strips were provided for investigation where they were tested using a retention meter and retention controls.Testing results (qc range = 2.4 - 3.6 inr): qc 1: 3.0 inr, qc 2: 3.0 inr, 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 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
• 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: 13841340
• MDR Text Key: 294394078
• Report Number: 1823260-2022-00801
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630946471
• UDI-Public: 04015630946471
• 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,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 07797826160
• Device Lot Number: 56099213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/21/2022
• Supplement Dates Manufacturer Received: 03/24/2022
• Supplement Dates FDA Received: 04/15/2022
• 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: DONEPEZIL; DOXYCYCLINE; FENOFIBRATE; FLUTICASONE; GEMTESA; LASIX; METHENAMINE; METOPROLOL; MONTELUKAST; SIMVASTATIN; VENLAFAXINE; WARFARIN
• Patient Age: 83 YR
• Patient Sex: Male