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

Catalog Number 04625374160

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The patient stated that he received erroneous results when testing with coaguchek xs meter serial number (b)(4).At 11:53 a.M., a sample from the patient resulted as 3.6 inr.At 11:57 a.M., the patient collected a sample from the same fingerstick by squeezing and this resulted as 2.7 inr.The patient reported the 2.7 inr value.No adverse events were alleged to have occurred with the patient.The patient did not receive treatment based on the meter results.The patient's therapeutic range is 2 - 3 inr.The patient's testing frequency is once every two weeks.The patient is not anemic or polycythemic.The patient does not have antiphospholipid antibodies.The patient does not take heparin, lovenox, or thrombin inhibitors.The patient did not have any changes in diet, medications, or illnesses.The patient had no bruising or bleeding.The patient injured his rib cage recently and only took tylenol for this.The meter had not been cleaned under the blue lid.The patient's product has been requested for investigation and replacement product was sent to the patient.Relevant retention test strips (lot 235609-23) were tested in comparison with the current master lot coaguchek xs pt test strip.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 patient's meter was received for investigation.The returned meter was tested in comparison to a retention meter and master lot strips.Human blood samples from warfarin donors were used.Donor 1 inr: 2.4 inr, donor 2 inr: 2.8 inr.Donor 1 hct: 47%, donor 2 hct: 38%.Testing results: donor 1: retention meter with master lot strips: 2.4 inr, customer meter with master lot strips: 2.4 inr.Donor 2: retention meter with master lot strips: 2.8 inr, customer meter with master lot strips: 2.8 inr.All inr values were within the specified maximum difference between measurements.No error messages occurred.The returned and the retention material meet the specifications.As the customer used the same fingerstick for multiple tests, this is a potential cause for the result discrepancy.Product labeling advises to use a different finger for each test performed.

• 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: 7392337
• MDR Text Key: 104415961
• Report Number: 1823260-2018-01029
• 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: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 04625374160
• Device Lot Number: 23560923
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: B3; FOLIC ACID; LIPITOR; LOSARTAN; MAGNESIUM; METFORMIN; PROZAC; TRICOR; VITAMINS-B COMPLEX; WARFARIN
• Patient Age: 74 YR
• Patient Weight: 87