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

Catalog Number 04625315019

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

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

Event Date 01/20/2023

Event Type  malfunction  

Manufacturer Narrative

Both the hospital's and the patient's meters and test strips were requested for investigation.The products have not been received at this time.If the products were 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.

Event Description

We received an allegation of questionable inr results for 1 patient tested with the hospital's coaguchek xs plus meter serial number (b)(4) compared to the patient's coaguchek xs meter serial number (b)(4).On (b)(6) 2023 the patient had a hospital's meter result of 3.0 inr while the patient's meter result was 2.2 inr.The patient's warfarin dose was changed based on the coaguchek xs plus meter's result.The patient's therapeutic range was not provided.The hospital runs controls monthly on coaguchek xs plus meter.The lot number of the test strips used on the hospital's coaguchek xs plus meter was 58078515.The lot number of the test strips used on the patient's coaguchek xs meter was 62682412 with an expiry date of 31-jan-2024.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16397497
• MDR Text Key: 310209391
• Report Number: 1823260-2023-00498
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04625315019
• Device Lot Number: 58078515, 62682412
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2023
• 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: WARFARIN
• Patient Sex: Male