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

Catalog Number 04625358016

Device Problem High Test Results (2457)

Patient Problem Ischemia (1942)

Event Date 01/15/2017

Event Type  Injury  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that a patient who performs testing with coaguchek xs meter serial number (b)(4) had an ischemic event in the eye on (b)(6) 2017 and was brought by ambulance to the hospital.On (b)(6) 2017, the patient was tested in parallel on the meter and with the stago sta-r laboratory method.The results from the parallel testing are as follows: (b)(6) 2017: meter result = 3.6 inr, sta-r result = 2.3 inr; (b)(6) 2017: meter result = 3.1 inr, sta-r result = 2.38 inr; (b)(6) 2017: meter result = 2.6 inr, sta-r result = 2.12 inr; (b)(6) 2017: meter result = 2.7 inr, sta-r result = 2.1 inr.As the results from the meter were significantly higher, clinicians concluded that the patient's anticoagulant therapy was insufficient and this led to the ischemic event.The physician prescribed a new coaguchek xs meter to the patient.The current condition of the patient was asked for, but is not known.It was also asked if the patient experienced any further adverse events as a result of the ischemia, but this is not known.The patient's therapeutic range is 2.5 - 3.5 inr.The patient is a heart patient and has a mechanical heart valve since 2001.The patient takes sintrom medication daily.The patient's product was requested for investigation.Relevant retention test strips (lot 119116-10) were tested in comparison with the current master lot coaguchek xs pt test strip (lot 124158-80).For this purpose two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.Retention samples were within specifications.

Manufacturer Narrative

The customer's meter and a test strips were provided for investigation.The test strips and vial showed no defects.The meter appeared to be undamaged and clean on the outside.The returned test strips were measured with the returned meter, in comparison with relevant retention test strips (lot 119116) and the current master lot coaguchek xs pt test strip (lot 124158-80).For this purpose two human blood samples from marcumar donors and internal reference meters were used.Results: donor 1: master lot with reference meter: 2.0 inr.Customer strips with customer meter: 2.0 inr.Donor 2: master lot with reference meter: 3.8 inr.Customer strips with customer meter: 3.9 inr.The maximum difference between measurements with the same blood sample was 0.1 inr.The returned customer material and retention material are within specifications.Medwatch fields d10 and h3 have been updated.

Manufacturer Narrative

The investigation results for donor 2 were initially stated incorrectly.The correct information is as follows: donor 2: master lot with reference meter: 3.8 inr, customer strips with retention strip: 3.9 inr.Medical assessment of the event was performed.Anticoagulant therapy with vitamin k antagonists is known to reduce the risk of stroke.However, there are individual factors (mechanical valve, comorbidities) that can contribute or lead to a thrombosis and ischemic event.No product problem was found.

• Brand Name: COAGUCHEK ® XS SYSTEM
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6385604
• MDR Text Key: 69324119
• Report Number: 1823260-2017-00500
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: LU
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2017

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625358016
• Device Lot Number: 11911616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2017
• Initial Date FDA Received: 03/07/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/05/2017; 04/24/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: MECHANICAL HEART VALVE; SINTROM (DAILY)
• Patient Outcome(s): Hospitalization