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

Catalog Number 6802413

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that 2 lower than expected vitros amon results were obtained from a quality control fluid using vitros amon slide lot 1017-0245-8848 tested on a vitros 5600 integrated system (b)(4).The most likely assignable cause of the lower than expected vitros dgxn quality control result is an instrument performance issue, as a within-run vitros amon precision test was outside performance guidelines, indicating that the vitros 5600 integrated system was not performing as intended.Following service actions which included replacement of the evaporation caps and the collection assembly and mirror/illuminator lens kit, acceptable vitros amon precision results were obtained, indicating service actions had returned the vitros 5600 system to expected performance.As the reagent lot was changed after service actions were complete, vitros amon slide lot 1017-0245-8848 cannot be completely ruled out as a contributing factor.

Event Description

A customer reported imprecise quality control results (qc) using vitros clinical chemistry products ammonia (amon) slides on a vitros 5600 integrated system.Vitros liquid performance (lot a5363) results of 148.1 and 135.7 umol/l compared to an expected result of 192.3 umol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected.Although there were no reports of affected patient sample results, it cannot be confirmed that patient sample results were not affected or would not be affected if the event were to recur undetected.There was no allegation of patient harm as a result of this 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: 6841639
• MDR Text Key: 85950236
• Report Number: 1319681-2017-00072
• 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: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• 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: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1