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

Catalog Number 04625315019

Device Problem High Test Results (2457)

Patient Problems Ischemia Stroke (4418); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2022

Event Type  Injury  

Event Description

We received an allegation that a patient had a stroke while using coaguchek xs meter serial number (b)(4).There was also an allegation of discrepant results between the coaguchek xs meter and unknown laboratory methods.On (b)(6) 2022, the patient allegedly had a stroke due to thromboembolism from a prosthetic valve.On that date, the result reported to be from the meter was 2.0 inr.No other comparative measurements were made.The patient alleges the inr result was "actually well below 2.0" inr at that time since a value of 2.0 inr is within his therapeutic range of 2.0 to 3.0 inr, and "stroke cannot occur at this inr." on (b)(6) 2022 the result from one laboratory from an unknown laboratory method was reportedly 2.9 inr.The result from a different laboratory using an unknown method was reportedly 3.66 inr.The result from the meter was reportedly 4.0 inr.All tests were performed within 4 hours.The lot number of the test strips used for this test was not provided and the strips are not available for investigation.On (b)(6) 2023, at 8:17 a.M.The result from the meter was reportedly 7.5 inr.Within one hour, the result from an unknown laboratory method was reportedly 4.63 inr.The lot number of the test strips used for this test was 60124817 with an expiration date of 31-oct-2023.The patient's therapeutic range was reportedly 2.0 to 3.0 inr.

Manufacturer Narrative

Occupation is patient/consumer (patient's sister).The lot number of the test strips used for the meter result of 7.5 inr was 60124817 with an expiration date of 31-oct-2023.The lot number of the test strips used for the meter result of 4.0 inr was not provided and the strips are not available for investigation.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 patient's meter was checked by the service center and all test results were within range.The meter was returned to the patient.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.

Manufacturer Narrative

H6 codes were updated.

• 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: 16358818
• MDR Text Key: 309364827
• Report Number: 1823260-2023-00431
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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: 03/17/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 04625315019
• Device Lot Number: 60124817, ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 02/10/2023
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 03/17/2023
• 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
• Patient Outcome(s): Other
• Patient Sex: Male