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

Catalog Number 6802413

Device Problem Low Test Results (2458)

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

Event Date 05/23/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a non-reproducible, lower than expected amon result was obtained from a quality control fluid when using a vitros 5600 integrated system.The most likely assignable cause is an instrument issue related to incubator contamination.Following maintenance actions by an ortho field engineer, vitros amon within-lab precision and within-run precision were significantly improved.

Event Description

A customer reported a non-reproducible, lower than expected amon result obtained on a quality control fluid processed using a vitros 5600 integrated system.Amon result = 150.0 umol/l vs.Expected 199.2 umol/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action, should they occur undetected on patient samples.The customer made no allegation that amon patient results were affected.There was no allegation of patient harm.(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: 5745194
• MDR Text Key: 49157647
• Report Number: 1319681-2016-00156
• Device Sequence Number: 0
• Product Code: JIF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/26/2016
• Initial Date FDA Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2010
• 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