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

Catalog Number 04625315160

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2015

Event Type  malfunction  

Event Description

The first nurse from the home health facility called about obtaining an error 5 and error 6 on the patient while attempting to test with the coaguchek xs (serial number (b)(4)).The nurse was assisted to run a test while on the phone with the company agent and a result of 5.8 inr was obtained.She had no further questions about the result or the meter.A second nurse called back and reported obtaining an error 5 with the same patient on the same meter.The company agent then assisted the second nurse to test the patient again and a result of 7.7 inr was obtained 15 minutes after the result of 5.8 inr.The same vial of strips and different fingers were used for the results.It was reported that the inr result for the patient was high.The patient was sent to the hospital to test the inr with the lab.A lab result of 3.0 inr was obtained an hour or so after the 7.7 inr result.The nurse does not know if the lab uses the dade innovin reagent.The patient was not admitted to the hospital and no treatment was received.She is currently feeling "okay".It is reported that no changes were made to the customer's medication.The patient is not on heparin, is not anemic and does not have any antiphospholipid antibodies.It was reported that the patient has not had any special or unusual diet.The patient last took 2.5 mg warfarin in the morning of (b)(6) 2015.The qc check was seen while running the tests.There was no adverse event.

Manufacturer Narrative

Relevant retention test strips (lot 29392512) were tested in comparison with the current master lot coaguchek xs pt test strip (lot 230734-80) no error messages occurred.Retention samples were acceptable.

Manufacturer Narrative

The suspect product was not returned.No further information available at this time.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5243189
• MDR Text Key: 32144581
• Report Number: 1823260-2015-04620
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 04625315160
• Device Lot Number: 29392512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Ambulatory Health Care Facility
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 11/23/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/04/2015; 01/05/2016
• 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