MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK VANTUS; PROTHROMBIN TIME MONITOR

Model Number COAGUCHEK INRANGE

Device Problem Application Program Problem (2880)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation is lay user/patient.The customer's meter and test strips were requested for return for investigation.The investigation is ongoing.

Event Description

The initial reporter complained of an issue with coaguchek vantus meter serial number (b)(4).It was noted that a code chip for a different unexpired lot number was installed in the meter.The customer tried using test strip lot number 30497423 that expired on 31-oct-2019, but the meter failed to provide a fail-safe warning that they were using expired test strips and the customer obtained a result.The actual result received was not provided.

Manufacturer Narrative

The meter was not received for investigation.M-22 (expired strip error code), is triggered whenever the vantus meter recognizes an expired test strip if the date setting on the device is accurate and labeling instructions for taking a test are followed.On 16-feb-2021, a test was performed utilizing a retention meter, a test strip and code chip from lot number 3534991, and an expiration date of 30-apr-2020.The m-22 error code was triggered.Per labeling instructions, "if you are using test strips from a new, unopened box, you will need to change the test strip code chip.The 3-number code on the test strip container must match the 3-number code on the code chip".Medwatch field h3 was updated.

• Brand Name: COAGUCHEK VANTUS
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11174018
• MDR Text Key: 249620130
• Report Number: 1823260-2021-00181
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K170960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

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 Model Number: COAGUCHEK INRANGE
• Device Catalogue Number: 07729952160
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1