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 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros amon results were obtained when testing non-vitros quality controls on a vitros 5600 integrated system.The assignable cause of this event was instrument related.The results of a diagnostic within run vitros amon precision test was not acceptable indicating an instrument related issue.After service actions were completed to clean the evaporation caps and adjusting the slide align guides, the precision was acceptable indicating service actions had returned the analyzer to acceptable performance.The customer continued to obtain unacceptable amon results and an issue was identified involving the slide supply humidity affecting quality control results for multiple assays.After the ortho fe replaced the humidity plate, post-service quality control testing was acceptable indicating the actions have resolved the issue.Since unacceptable performance was observed for multiple reagents including vitros amon and acceptable performance was observed after the service actions using the current reagent lot, vitros amon lot 1017-0245-0578 can be ruled out as a contributing factor.

Event Description

The customer observed lower than expected vitros amon results when testing a non-vitros quality control fluid on a vitros 5600 integrated system.Biorad quality control level 3 lot 54193 vitros amon results 139.1 and 145.5 umol/l versus expected 259.99 umol/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action.The vitros amon results were obtained when testing non-vitros quality control samples.There was no allegation of patient harm as a result of the event.(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: 6792806
• MDR Text Key: 82938445
• Report Number: 1319681-2017-00064
• Device Sequence Number: 0
• Product Code: JIF
• 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
• Type of Report: Initial
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• 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: 07/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2015
• 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