MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GMBH COAGUCHEK XS PLUS (TEST STRIPS); TEST, TIME, PROTHROMBIN

Lot Number 49408211

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Date 04/07/2021

Event Type  malfunction  

Event Description

(b)(6) clinic receiving multiple error 407 (failure of onboard controls) for roche coaguchek xs plus meter while using test strips with lot number 49408211 and expiration 3/31/2022.Two failures were noted out of a vial (24 test strips per vial).Use of the vial was suspended after the two failures.Not all test strips from the affected vials failed.Test strip reported error message 407 once a droplet of blood was applied.Machine immediately displayed error 407 and would not record a result.This was noted on one roche coaguchek xs plus machine by one pharmacist performing the point of care testing.This occurred while testing multiple patients (not all errors were related to one patient.) roche has been notified of the concern, and we have been asked to send vials with failing test strips back to roche for further testing/analysis.(this is why there is only one pharmacist and machine as part of this report.) package of 48 strips.Fda safety report id # (b)(4).

• Brand Name: COAGUCHEK XS PLUS (TEST STRIPS)
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 11648116
• MDR Text Key: 245185432
• Report Number: MW5100690
• Device Sequence Number: 1
• Product Code: GJS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/07/2021
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 03/31/2022
• Device Lot Number: 49408211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1