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

Catalog Number 04625374160

Device Problem Device Markings/Labelling Problem (2911)

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.

• 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: 6588350
• MDR Text Key: 75873339
• Report Number: 1823260-2017-01088
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/22/2017

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: 17619123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/26/2017
• Initial Date FDA Received: 05/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2017
• 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