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

Catalog Number 04625315160

Device Problem High Test Results (2457)

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

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received questionable result from coaguchek xs meter serial number (b)(4).The result at 14:31 was > 8.0 inr.The result at 14:34 was 6.7 inr using the same fingerstick.The result at 14:34 was 5.3 inr using a different hand and finger.A sample was sent to the laboratory for confirmation and the result at 17:25 was 4.4 inr using a acl tops analyzer (not dade innovin reagent).There was no allegation of an adverse event.The patient's therapeutic range was 2.5 - 3.0 inr.The suspect meter and strips were requested to be returned for investigation.Replacement product was sent.Relevant retention test strips (lot 176193-12) 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 retention material performed as specified.

Manufacturer Narrative

The returned meter and test strips were tested in comparison to a retention meter an masterlot strips.Two human blood samples from warfarin donors and internal reference meters were used.Donor inr: 2.9 inr and 2.0 inr, donor hct: 53% and 45%.Donor #1: master lot / customer meter and master lot strips 3.0 inr/ 3.0 inr.Donor #2: master lot / customer meter and master lot strips 2.0 inr/ 2.0 inr.All results were within the specified maximum difference between measurements.No error messages occurred.The returned and the retention material met the specification.No information was provided in the complaint case that would point to a cause for the result discrepancy.

• 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: 7141611
• MDR Text Key: 95823644
• Report Number: 1823260-2017-03108
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

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: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 04625315160
• Device Lot Number: 17619312
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 12/14/2017
• Supplement Dates FDA Received: 01/11/2018
• 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