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 01/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device not returned.

Event Description

The patient stated that she received erroneous results when testing with coaguchek xs meter serial number (b)(4).At 9:10 a.M., a sample from the patient was tested on the meter and the result was 6.0 inr.At 9:16 a.M., a sample from the patient was tested on the meter and the result was 4.4 inr.At 9:21 a.M., a sample from the patient was tested on the meter and the result was 6.2 inr.The patient stuck the same finger 3 different times in order to obtain the three samples used for measurement.The patient believed all results to be incorrect and did not report any of these results to her doctor.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 per week.The patient does not have any hematocrit issues and does not have antiphospholipid antibodies.The patient does not use heparin or direct thrombin inhibitors.The patient's warfarin dose was reduced based on a result of 3.6 inr obtained on (b)(6) 2018.The patient last took warfarin medication 11 hours prior to the event.The patient has not had any changes in normal vitamins or supplements prior to the event.The patient has not had any changes in diet and does not have a special or unusual diet.The patient has no bleeding or bruising.The patient's product was requested for investigation and replacement product was sent to the patient.Relevant retention test strips (lot 247896-23) were tested in comparison with the current master lot.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.Upon review of the meter memory, additional discrepant data was observed as follows: on (b)(6) 2016 at 09:56, there was a result of 4.6 inr.On (b)(6) 2016 at 10:30, there was a result of 1.8 inr.The patient's meter was provided for investigation.The returned meter was measured with master lot strips in comparison to a retention meter and master lot strips.Two human blood samples from warfarin donors and internal reference meters were used.Donor 1 inr: 2.1 inr donor 2 inr: 2.1 inr donor 1 hct: 44% donor 2 hct: 48% testing results: donor #1: master lot: 2.1 inr customer meter and master lot: 2.1 inr donor #2: master lot: 2.1 inr customer meter and master lot: 2.1 inr all inr values were within the specified maximum difference between measurements.The patient samples were always identified as blood.No error messages occurred.The returned material and the retention material meet specifications.A possible cause for the discrepancy is the customer used the same finger for all three tests.Per product labeling, the customer is instructed to use a sample from a new finger for each test.

• 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: 7237402
• MDR Text Key: 99776453
• Report Number: 1823260-2018-00314
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 04625374160
• Device Lot Number: 24789623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2018
• 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
• Patient Age: 74 YR
• Patient Weight: 74