MAUDE Adverse Event Report: ROCHE ROCHE COBAS; COBAS E411

Model Number COBAS E411

Device Problem False Negative Result (1225)

Patient Problem Venipuncture (2129)

Event Date 01/08/2017

Event Type  malfunction  

Event Description

It was discovered that the roche e411 lab machine had incorrect dilution settings programmed for hcg, tsh, and bnp.We reviewed patients that had labs ran on the machine and found this patient potentially had a false negative reading on her blood hcg on (b)(6).The patient returned on (b)(6) and had a positive hcg screening.The machine has been pulled from service and will be evaluated by roche.

• Brand Name: ROCHE COBAS
• Type of Device: COBAS E411
• Manufacturer (Section D): ROCHE; mannheim DE
• MDR Report Key: 6300658
• MDR Text Key: 66597613
• Report Number: MW5067652
• Device Sequence Number: 1
• Product Code: CGN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COBAS E411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Age: 27 YR
• Patient Weight: 79