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

Catalog Number 07671687019

Device Problems No Device Output (1435); High Test Results (2457); Output Problem (3005)

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

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

The meter and strips were requested for investigation.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.".

Event Description

There was an allegation of questionable results from coaguchek inrange meter, serial number (b)(6), compared to a laboratory result using an unknown method.The meter result was 3.0 inr.The laboratory result was 5.0 inr.A second roche coagulation meter gave a result of 5.0 inr.The patient¿s therapeutic range is 2.5 - 3.0 inr.

Manufacturer Narrative

The customer's meter and test strips were provided for investigation where they were tested using retention controls.Testing results (qc range = 2.4 - 3.6 inr): qc 1: 2.8 inr.Qc 2: 3.0 inr.Qc 3: 2.9 inr.The customer's meter was also tested with retention strips using retention controls.Testing results (qc range = 2.4 - 3.6 inr): qc 1: 2.9 inr in two additional measurements with retention strips, error message e-64 was triggered.Per product labeling, "meter error [e-64]; test strip reader error.Power meter off and on.If error persists, contact roche diagnostics." the obtained qc values were in the allowed range of the used combination strip lot - qc lot.The reported result of 3.0 inr was found with on the following dates in the result memory log: (b)(6) 2023, (b)(6) 2023, (b)(6) 2022, and (b)(6) 2021.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COAGUCHEK XS PT TEST PST
• 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: 18464448
• MDR Text Key: 332312573
• Report Number: 1823260-2024-00071
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): Y
• Reporter Country Code: AS
• 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: 02/29/2024

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: 07671687019
• Device Lot Number: 65779412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 02/29/2024
• 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
• Patient Sex: Male