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

Catalog Number 04625358003

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 01/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer received questionable results from coaguchek xs meter serial number (b)(4).Different fingers were used for each testing.(b)(6).There was no allegation of an adverse event.The meter and strips were requested to be returned for investigation.Relevant retention test strips (lot 258636-10) were tested in comparison with the master lot coaguchek xs pt.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 retention material complied with specification.

Manufacturer Narrative

The customer did not return any materials for investigation.The investigation was unable to find a definitive root cause.

Manufacturer Narrative

The customer meter was returned for investigation.The returned meter was measured with retention strips in comparison to a reference meter and master lot strips.Two human blood samples from warfarin donors and internal reference meters were used.Testing results: marcumar 3: reference meter and master lot strips: 2.8 inr, customer meter and retention strips: 2.7 inr.Marcumar 4: reference meter and master lot strips: 3.4 inr, customer meter and retention strips: 3.3 inr.Returned customer material and retention material complies with specification.

• 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: 7237698
• MDR Text Key: 99190703
• Report Number: 1823260-2018-00317
• 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,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2018

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: 02/28/2019
• Device Catalogue Number: 04625358003
• Device Lot Number: 25863611
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 115