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

Catalog Number 04625315160

Device Problem Circuit Failure (1089)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi) # (b)(4).This report was initially provided to roche by fda via medwatch: mw5100567.The customer¿s strips were requested for return.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.Routine retention testing was performed.Test strip retention samples passed the internal inspection.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

There was a complaint of error messages with coaguchek xs plus meter serial number (b)(4).The customer loaded the testing strip into the meter and added a sample.The meter then beeped and required a new sample and strip.The second strip would read the finger sample to produce a result and this occurred 6-7 times from the same tube of test strips.The customer did not remember the error message that she received with the test strips, that it "could have been e-407 but she was not sure" and stated that it would happen before she could even apply blood to the test strips.

Manufacturer Narrative

The reporter returned 1 test strip for investigation where it was tested using retention controls.Testing results (qc range = 2.1- 3.3 inr): qc 1: 2.4 inr.The obtained qc value was in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The investigation of the customer material didn´t confirm the complained error.Qc error generally occurs when test strips are exposed to moisture or light sources.However, it is known that slight disturbances of the test strip composition can trigger the inbuilt failsafe-mechanism of the test strip, and thus can cause this error messages.Such disturbances are isolated events that cannot be completely excluded with individual test strips.Medwatch fields d9 and h3 have been updated.

• Brand Name: COAGUCHEK XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11832420
• MDR Text Key: 250893079
• Report Number: 1823260-2021-01452
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• 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 Catalogue Number: 04625315160
• Device Lot Number: 49408211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1