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

Catalog Number 04625358003

Device Problems Device Expiration Issue (1216); Device Markings/Labelling Problem (2911)

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.

• 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: 6497592
• MDR Text Key: 72992398
• Report Number: 1823260-2017-00794
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 04625358003
• Device Lot Number: 22929311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2017
• 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: N
• Patient Sequence Number: 1