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

Catalog Number 07762798003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Coagulation Disorder (1779)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

The patient's product was 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.Relevant retention test strips (lot 393936) were tested in comparison with the master lot coaguchek xs pt at roche mannheim.For this purpose two human blood samples from marcumar donors and two internal reference meters were used.Retention samples were acceptable.No error messages occurred.

Event Description

The initial reporter stated that they suspect a patient's coaguchek inrange meter serial number (b)(4) did not perform measurements correctly.At 20:23 on (b)(6) 2019, a sample from the patient was measured using the meter, resulting with a value of 2.7 inr.On (b)(6) 2019, the patient had a stroke.The patient was admitted to the hospital on an unknown date.At the time of admission, a sample from the patient was tested in the laboratory using an unknown thromboplastin method, resulting with a value of 2.1 inr.The patient's therapeutic range is 2.5 - 3.0 inr.The patient's testing frequency is one to two times per week.The patient should receive a heparin injection if her inr is below 2.5 inr.The patient's language center was impaired.As of (b)(6) 2019, the patient is still in the hospital due to the stroke.

Manufacturer Narrative

The patient has a mechanical heart valve.The patient's remaining test strips and meter were provided for investigation where they were tested with retention control material.The test strips and vial showed no defects.The meter appeared clean and undamaged.Quality control range 2.4 - 3.0 inr.Testing results for meter serial number (b)(4) and test strip lot 39393612: quality control results 2.7 inr, 2.7 inr, 2.7 inr.All inr values were within the specified target ranges, confirming the functionality of the coaguchek measuring system.No error messages occurred.Returned customer material and retention material comply with the specification.

Manufacturer Narrative

The patient provided additional information which is attached the this medwatch.The data includes marcumar dosages and inr measurements from the weeks of 01-jul-2019 through the end of week 02-sep-2019.Each row of the attachment represents information for the week starting on the date in the first column.The times and dates for each of the additional inr measurements performed during the week (seen in last column) are not known.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8940015
• MDR Text Key: 160534178
• Report Number: 1823260-2019-03139
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 07762798003
• Device Lot Number: 39393612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Date Manufacturer Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BISOHEXAL; CONTRACEPTION PILL; HEART VALVE; IRON TABLET; MARCUMAR; TYRONAIOD
• Patient Outcome(s): Hospitalization
• Patient Age: 45 YR
• Patient Weight: 53