• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS Back to Search Results
Catalog Number 04625358003
Device Problems Label (862); Device Expiration Issue (1216); Device Markings/Labelling Problem (2911); Test Strip (3121)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/20/2017
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

The customer complained of an error 3 on the coaguchek xs meter. Error 3 means that the test strip expiration date is lower than the date set on the meter. It is not known if the date on the meter was set correctly. This information was requested but was not provided. During troubleshooting for this complaint, the customer stated that the expiration date on the strip vial was 05/31/2017. According to information available, the expiration date for strip lot 229293-11 is 01/31/2016. There was no allegation that an adverse event occurred. The test strips were requested for investigation.

 
Manufacturer Narrative

Clarification was received that the customer's date was set correctly on the meter at the time of the event.

 
Manufacturer Narrative

The customer has not returned the test strips. Relevant retention test strips (lot 229293-11) shows the correct expiration date 01/31/2016. The expiration date on the retention vial matches the expiration date in material records. Retention material was acceptable. A specific root cause was not identified for this event. Since the test strips were not returned, the investigation could not be completed.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCOAGUCHEK ® XS SYSTEM
Type of DevicePROTHROMBIN 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 Key6497592
MDR Text Key72992398
Report Number1823260-2017-00794
Device Sequence Number1
Product Code GJS
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK062925
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,FOREIGN
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup
Report Date 05/17/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/17/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2016
Device Catalogue Number04625358003
Device LOT Number22929311
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2017
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

-
-