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

Catalog Number 07762798003

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 04/01/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).This event occurred in (b)(6).

Event Description

The customer complained of questionable inr results from coaguchek in range meter serial number (b)(4).The coaguchek in range meter is not approved for distribution nor is like or similar to a product approved for distribution in the united states.At 08:00 pm the result was 1.4 inr and at 08:09 pm the result was 2.5 inr.The customer was not sure if the results were from the same sample or not.Clarification has been asked but not provided.There was no allegation of an adverse event.The patient's therapeutic range was 2.0 - 3.0 inr.The suspect product was requested to be returned for investigation.The customer's returned meter was tested with retention test strips (lot 235473) in comparison to masterlot strips.Two human blood samples from marcumar donors and internal reference meters were used.Donor #1: masterlot and reference meter: 2.8 inr.Donor #1: retention strips and customer meter: 2.7 inr.Donor #2: masterlot and reference meter: 3.1 inr.Donor #2: retention strips and customer meter: 3.0 inr.All inr values were within the specified maximum difference between measurements.The returned material and the retention material meet the specifications.Relevant retention test strips (lot 235473) 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.Retention samples were acceptable.No error messages occurred.The investigation was unable to find a definitive root cause.

• 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: 7490964
• MDR Text Key: 108163011
• Report Number: 1823260-2018-01402
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 07762798003
• Device Lot Number: 235473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2018
• 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: 79 YR
• Patient Weight: 110