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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received questionable results from coaguchek xs meter serial number (b)(4).The customer received an error "6" and then got a result of 8.0 inr at 1:11 pm using strip lot 12804321.It was determined the meter was incorrectly coded, so the customer recalibrated to a new strip lot, 15288521.The customer retested within one hour with a new finger and the result was 6.0 inr.Refer to the medwatch with patient identifier (b)(6) for the mdr for test strip lot 15288521.The customer was to follow up with his physician regarding the results as he did not think either result was accurate.There was no adverse event.The therapeutic range was 2-3 inr.The patient was not anemic, was not on heparin or a direct thrombin inhibitor, and had no antiphospholipid antibodies.The strips were requested to be returned for investigation.

Manufacturer Narrative

One vial of test strip lot 128043-21 was received for investigation.The returned test strips were measured with a retention meter in comparison to a retention meter and masterlot strips.Two human blood samples from warfarin donors and internal reference meters were used.Donor 1: masterlot and retention meter / customer strips and retention meter 2.7 inr/ 2.9 inr.Donor 2: masterlot and retention meter / customer strips and retention meter 2.3 inr / 2.4 inr.All values were within the specified maximum difference between measurements.No error messages occurred.The returned and the retention material meet the specification.Relevant retention test strips (lot 128043-21) 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 acceptable and performed as specified.

• 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: 6194111
• MDR Text Key: 63068412
• Report Number: 1823260-2016-02040
• 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,Followup
• Report Date: 01/13/2017

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: Lay User/Patient
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 04625374160
• Device Lot Number: 12804321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2017
• 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: WARFARIN
• Patient Age: 69 YR
• Patient Weight: 146