MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PROF KIT; COAGUCHEK ® XS SYSTEM

Catalog Number 04837975001

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 03/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The pharmacist reported segments were missing from the results field of the meter display.A display check was performed and it was determined that segments were missing from the three "8's" of the result field of the display.There was no allegation that any result was interpreted incorrectly due to the issue.There was no allegation of any adverse event.The meter was requested to be returned for further investigation.

Manufacturer Narrative

A specific root cause could not be determined.As no product was returned for investigation, further investigation was not possible.

• Brand Name: COAGUCHEK XS PROF KIT
• Type of Device: COAGUCHEK ® XS SYSTEM
• 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: 6630919
• MDR Text Key: 77515870
• Report Number: 1823260-2017-01201
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 07/27/2017

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: Health Professional
• Device Catalogue Number: 04837975001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2017
• Initial Date FDA Received: 06/09/2017
• Supplement Dates Manufacturer Received: 03/06/2017
• Supplement Dates FDA Received: 07/27/2017
• 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