MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS 5600 INTEGRATED SYSTEM; CHEMISTRY ANALYZER

Catalog Number 6802413

Device Problems Nonstandard Device (1420); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a patient sample was potentially dispensed into an unintended tube/cup.The investigation identified a software anomaly associated with a specific sequence of events, which allows aspiration of a sample from an unintended tube/cup and/or return of an aspirated sample into an unintended tube/cup position of a sample tray using a vitros 5600 integrated system.This can lead to the generation and reporting of a test result, or series of results, that do not reflect the patient¿s condition and could lead to inappropriate intervention with the potential for serious injury to the patient.The fda (b)(4) district office was notified of this issue on 13 april 2016.Refer to report number 1319681-4/13/2016-001-c.(b)(4).

Event Description

In support of an ortho clinical diagnostics (ortho) investigation a customer's results were reviewed and it was determined that a sample fluid was potentially dispensed into an unintended tube/cup on the sample tray.Undetected dispensing into a tube/cup other than the intended could lead to the generation and reporting of a test result, or series of test results, which do not reflect the patient's condition.This in turn could lead to inappropriate intervention with the potential for serious injury to the patient.Ortho contacted the customer to inform them of the event.The customer reviewed their results and informed ortho that none appeared to be discordant, however contamination and the reporting of erroneous results to a clinician cannot be entirely ruled out.There has been no allegation of patient harm, however the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.This report corresponds to ortho clinical diagnostics (ortho) complaint number (b)(4).

• Brand Name: VITROS 5600 INTEGRATED SYSTEM
• Type of Device: CHEMISTRY ANALYZER
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 5740459
• MDR Text Key: 48762245
• Report Number: 1319681-2016-00153
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6802413
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1