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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problem Pulmonary Embolism (1498)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

The reporter's product was requested for investigation and replacement product was sent to the reporter.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.Coaguchek uses human recombinant thromboplastin.Therefore, 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.Reporter occupation - the occupation is lay user/patient.

Event Description

The initial reporter stated that he received discrepant results when testing with coaguchek xs meter serial number (b)(4).The patient alleged that use of the meter contributed to a pulmonary embolism he had approximately one year prior to (b)(6) 2020.The specific date of the event is not known.The patient stated that when he was admitted to the hospital he performed a result comparison with his meter and the laboratory method.The patient could not recall the exact values.The patient stated that a sample was tested on a stago laboratory analyzer using neoplastin reagent, resulting in a value of 1.5 inr.The patient sample was tested using the meter, resulting in a value between 2 and 3 inr.The patient stated that both samples were drawn within 4 hours of each other.The patient's therapeutic range is 2.0 - 3.0 inr.The patient's testing frequency is weekly.The patient was admitted to the hospital for two days.He received a 120 mg.Lovenox shot in the stomach.The patient had a blood panel completed and a chest x-ray with contrast, which confirmed a pulmonary embolism of the left lung.The patient did not require surgery.Information about additional treatment received during hospitalization, inr results within 2 weeks prior to the event, coumadin schema within 2 weeks prior to the event, or other meter to laboratory comparison values were requested.The patient could not provide any further information as he could not recall.

Manufacturer Narrative

For years, patient takes a centrum multivitamin that contains 60 mcg vitamin k.Vitamin k has an influence on the coagulation.Therefore, it should be clarified with the patient's doctor if that multivitamin is recommended in combination with the treatment for anticoagulation.

• 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: 10279990
• MDR Text Key: 199918201
• Report Number: 1823260-2020-01705
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

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 Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 06/17/2020
• Supplement Dates FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRUM MULTIVITAMIN; COUMADIN; DILTIAZEM
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Weight: 109