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 Consequences Or Impact To Patient (2199)

Event Date 06/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A trainer from alere complained of questionable inr results from the customer's coaguchek xs meter serial number (b)(4) compared to the alere's coaguchek xs meter serial number (b)(4).A different finger was used for each measurement except that the alere meter result of 4.5 inr and the customer's meter result of 3.2 inr were from the same finger.The inr results from the alere meter were deemed to be correct as the results from this meter and strip lot were comparable to the laboratory result of 4.0 inr from 2 weeks prior.The laboratory method used was not provided.The patient's therapeutic range was 2.0 inr to 3.0 inr.There were no treatment or actions taken based on results from the customer's meter.There were no changes in patient's medications.The patient is not anemic, not on heparin, no antiphospholipid antibodies, on no direct thrombin inhibitors, no changes in warfarin, on no new medications, has no additional illnesses, and no signs of bleeding or bruising.The patient did state they were eating more fruits and vegetables to lose weight, along with drinking more water.The suspect meter and strips were requested to be returned for investigation.The strip lot used on the alere meter was 23547622 with and expiration date of 30-nov-2018.Retention test strips (lot 235476) 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 acceptable.Relevant retention test strips (lot 286319) 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 acceptable.

Manufacturer Narrative

The customer meter and strips was returned for investigation.The returned meter and strips were tested in comparison to a retention meter and master lot strips.Human blood samples from warfarin donors were used.Donor 1 inr: 3.0 inr, donor 2 inr: 2.7 inr, donor 1 hct: 58%, donor 2 hct: 58%.Testing results: vial# 00156229.Donor 1: retention meter with master lot strips: 3.0 inr , customer meter with customer strips: 2.9 inr.Donor 2: retention meter with master lot strips: 2.7 inr, customer meter with customer strips: 2.8 inr.Vial# 00035081 , donor 1: retention meter with masterlot strips: 3.0 inr, customer meter with customer strips: 3.1 inr.Donor 2: retention meter with masterlot strips: 2.7 inr, customer meter with customer 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.The customer reported that the same fingerstick was used to acquire the alleged results.The use of the same fingerstick to dose multiple tests has been known to effect the accuracy of the test results.

• 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: 7654214
• MDR Text Key: 112862180
• Report Number: 1823260-2018-02171
• 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: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 04625374160
• Device Lot Number: 28631921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Date Manufacturer Received: 06/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BUSPIRONE; CLARITIN; COUMADIN; OMEPRAZOLE; OXYCODONE; SINGULAR; SYNTHROID; XANAX; BUSPIRONE; CLARITIN; COUMADIN; OMEPRAZOLE; OXYCODONE; SINGULAR; SYNTHROID; XANAX
• Patient Age: 56 YR
• Patient Weight: 72