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

Catalog Number 04625315003

Device Problem High Test Results (2457)

Patient Problems Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 01/01/2023

Event Type  Injury  

Event Description

The initial reporter alleged questionable results from coaguchek xs meter serial number (b)(4) and alleged an adverse event for the patient.The reporter alleged measurement differences between the coaguchek xs with different test strip batches compared to a laboratory on an unknown date last year.No specific results or dates could be provided.The patient allegedly had several mini-thromboses as a result.The patient¿s toe was reportedly discolored and the tissue died.The patient¿s toe was allegedly removed this year.The date of the event is an approximation.No specific date or other information was provided.The therapeutic range was 2.0-3.0 inr.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

The meter was requested for return.The test strips were no longer available.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." per product labeling: "the presence of anti-phospholipid antibodies (apas) such as lupus antibodies (la) may lead to prolonged clotting times, i.E., they may cause false-high inr values.If you have or suspect that you have apas, discontinue testing until you discuss with your physician.".

Manufacturer Narrative

The returned meter was measured with the retention test strips 57261210 in comparison to the current test strip master lot.For this purpose, two human blood samples from marcumar donors and internal reference meters were used.Reference meter: test 1: 3.5 inr, test 2: 2.5 inr.Customer meter: test 1: 3.3 inr, test 2: 2.4 inr.All inr values were within the specified target ranges, confirming the functionality of the coaguchek measuring system.No error messages occurred.The returned customer material and retention material comply with specifications.

• 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: 16714383
• MDR Text Key: 313042398
• Report Number: 1823260-2023-01212
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625315003
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2023
• 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: CORTISONE
• Patient Outcome(s): Other; Hospitalization