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

Catalog Number	04625358003
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Non Reproducible Results (4029)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	08/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
There was an allegation of a delay in treatment and a patient being hospitalized for a stroke after being unable to use the coaguchek xs meter.It was reported that the patient was unable to use the meter since 08-aug-2024 due to receiving an error message "error 4" on the meter.Product labeling for error 4 states: "the test strip is unusable or the sample has been applied too early (before the 180 seconds countdown begins)." due to the error message, the patient received a new coaguchek inrange meter on (b)(6) 2024.The patient did not go to the doctor between (b)(6) 2024 and the inr value was not determined.The (new) coaguchek inrange meter result on (b)(6) 2024 was 1.8 inr.The patient suffered a stroke on (b)(6) 2024.The laboratory result was 1.9 inr while the patient was in the hospital.The patient was treated in the hospital for her inr value, but additional information was not provided regarding treatment.The patient¿s therapeutic range is 2.0-3.0 inr.The patient's interval of testing is once a week.
Additional Manufacturer Narrative
Section e3: occupation is patient/consumer the coaguchek xs meter serial number is (b)(6).The coaguchek inrange meter serial number was not provided.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: 2.9 inr qc 2: 2.9 inr qc 3: 2.9 inr the customer's meter and retention test strips were tested using 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.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.The alleged error 4 (e-413) error was found in the meter memory log, but the error could not be reproduced during the investigation with the returned test strips.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COAGUCHEK XS PT TEST
• Common Device Name: 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: 20258459
• Report Number: 1823260-2024-02709
• Device Sequence Number: 7474379
• Product Code: GJS
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K062925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: 04625358003
• Device Lot Number: 76300711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WARFARIN
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 60 KG