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

Catalog Number 04625358016

Device Problem Non Reproducible Results (4029)

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

Event Date 11/20/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's meter is (b)(6).The serial number of the clinic's meter was requested, but not provided.The customer's meter was requested for investigation.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." section e3: occupation is patient/consumer.

Event Description

The customer stated they received discrepant results when testing with two coaguchek inrange meters.At 16:30, a sample from the patient was tested using the clinic's meter, resulting in a value of 2.7 inr.At 5:00, a sample from the patient was tested using the customer's meter, resulting in a value of 7.8 inr.At 5:15, a sample from the patient was tested using the customer's meter, resulting in a value of 3.8 inr.At 6:15, a sample from the patient was tested using the customer's meter, resulting in a value of 2.9 inr.The patient's therapeutic range is 2.5 - 3.0 inr.

Manufacturer Narrative

The customer's meter was returned for investigation where it was tested using retention strips and retention controls.Testing results (qc range = 2.4 - 3.6 inr): qc 1: 2,8 inr qc 2: 2.8 inr qc 3: 2,8 inr the obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.

• Brand Name: COAGUCHEK XS PT TEST
• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18302754
• MDR Text Key: 330182876
• Report Number: 1823260-2023-03934
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 01/05/2024

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: Lay User/Patient
• Device Catalogue Number: 04625358016
• Device Lot Number: 71519312
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/05/2024
• 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
• Patient Sex: Female