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 Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer has discarded the strips.

Event Description

A representative from coaguchek patient services (cps) called on behalf of the customer and explained that the customer was receiving errors on her coaguchek xs meter with an unspecified serial number.The representative also mentioned that the customer had received high, erroneous results on this meter.The representative attempted to connect the customer for further troubleshooting but the customer was no longer on the line.The customer was called back in an attempt to gather more details, but the customer disconnected the call.Additional attempts were made to gather more information related to this event, however, no further information has been provided.The customer tested initially on the meter at 8:56 a.M.And obtained a result of 3.9 inr.The customer tested on the meter again at 9:08 a.M.And the result was 5.7 inr.The customer¿s therapeutic range was not provided.No adverse event was reported.The representative indicated the customer had discarded the vial of strips.The customer was sent a postage paid label to return the meter for investigation.

Manufacturer Narrative

The customer did not return any product.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.No information was provided in the complaint that would point to a cause for the result discrepancy.Since no product was returned, the investigation could not be completed.

• 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: 6192892
• MDR Text Key: 62968001
• Report Number: 1823260-2016-02034
• 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: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/14/2017

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 Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• 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: 02/14/2017
• 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