MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PT TEST PST; PROTHROMBIN TIME MONITOR

Catalog Number 07671687016

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/22/2023

Event Type  malfunction  

Manufacturer Narrative

A retention meter was sent to the customer.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." section e3: occupation is patient/consumer.

Event Description

A customer stated they received discrepant results when testing with a coaguchek inrange meter.A sample from the patient was tested in the laboratory using the stago method, resulting in a value of 4.50 inr.Within 3 hours of laboratory testing, a sample from the patient was tested using the meter, resulting in a value of 6.1 inr.On (b)(6) 2023, a sample from the patient was tested in the laboratory using the stago method, resulting in a value of 4.03 inr.Within 3 hours of laboratory testing, a sample from the patient was tested using the meter, resulting in a value of 5.5 inr.On (b)(6) 2023, a sample from the patient was tested in the laboratory using the stago method, resulting in a value of 4.4 inr.Within 3 hours of laboratory testing, a sample from the patient was tested using the meter, resulting in a value of 6.4 inr.The patient's therapeutic range is 3 - 4 inr.

Manufacturer Narrative

The customer was provided a loaner coaguchek inrange meter (serial number unknown) and received additional discrepant values.On (b)(6) 2023, a sample from the customer's meter resulted in a value of 5.6 inr.At an unknown time on the same day, a sample from the patient was tested using the loaner meter, resulting in a value of 5.2 inr.At an unknown time on the same day, a sample from the patient was tested in the laboratory, resulting in a value of 4.1 inr.On (b)(6) 21023, a sample from the customer's meter resulted in a value of 4.4 inr.At an unknown time on the same day, a sample from the patient was tested using the loaner meter, resulting in a value of 4.5 inr.At an unknown time on the same day, a sample from the patient was tested in the laboratory, resulting in a value of 3.46 inr.

• Brand Name: COAGUCHEK XS PT TEST PST
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18158759
• MDR Text Key: 328383657
• Report Number: 1823260-2023-03647
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K170960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 07671687016
• Device Lot Number: 70302517
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WARFARIN.