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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS Back to Search Results
Catalog Number 04625374160
Device Problems Label (862); Device Markings/Labelling Problem (2911); Test Strip (3121)
Patient Problem No Patient Involvement (2645)
Event Date 04/26/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The customer complained that the labeling for 1 vial of coaguchek test strips was incomplete. The strip label had the red stripe along the top. The blue roche logo with the coaguchek colored ribbon was along the bottom. The black printed data documenting code, ref, lot, exp and gtin is not printed on the label. The customer had a 2nd strip vial that was being compared to this strip vial to determine what should be printed on the label. The customer could tell there were embossed strip vial numbers on the bottom of the vial but was unable to read them due to eyesight. The code number on the enclosed code chip is s_244. The customer did not run any tests with these strips since it was not possible to verify coding between the meter and strips. The test strip vial was requested for investigation. The test strip vial was returned for preliminary investigation without the box or the code chip. Based on the preliminary review of the returned vial, the label shows the roche redline with the roche logo and the coaguchek name. There was no lot specific information printed on the label. The investigation is ongoing.

 
Manufacturer Narrative

A picture of the returned vial was investigated further by the investigation unit and two potential root causes were identified for this issue. The issue could have occurred due to human error during the labeling of the strip vial where the operator did not notice the blank label or the label printer machine may not have recognized the label was blank. Lot number was updated. Relevant retention test strips (lot 176191-23) shows that the label was on the test strip vial. Retention samples were acceptable. This issue is highly detectable to the user and there is no medical risk to the user. A review of similar complaints indicates the frequency of this issue is low.

 
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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 Key6588350
MDR Text Key75873339
Report Number1823260-2017-01088
Device Sequence Number1
Product Code GJS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062925
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 06/22/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/24/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue Number04625374160
Device LOT Number17619123
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 Received04/26/2017
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

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