MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS 5,1 FS CHEMISTRY SYSTEM; CHEMISTRY ANALYZER

Catalog Number 6801375

Device Problem Low Test Results (2458)

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

Event Date 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that lower than expected vitros glu results were obtained when testing non-vitros quality control samples on a vitros 5,1 fs chemistry system.In addition, unexpected results were also observed across multiple assays on the same vitros 5,1 fs system.The assignable cause of the event is likely instrument related.The customer performed maintenance actions to the vitros 5,1 fs system.Following these actions the customer observed several condition codes and the quality control results for multiple assays were not within the customer¿s established baseline range.An ortho field engineer (fe) was sent to the site to mitigate the condition codes.The fe performed service actions including replacement of the immuno rate wash cam, interrupter optical switch, spring torsion drive pulley, bearing pads, and timing belt were completed to resolve the issue.The quality control results post service were acceptable for all assays including vitros glu.There was no evidence to suggest the vitros reagent malfunctioned.The historical glu qc data shows the reagent was performing as expected.

Event Description

A customer obtained lower than expected vitros glu results from non-vitros quality control samples on a vitros 5,1 fs chemistry system.Non-vitros multichem (lot 15706161) level 1 vitros glu result <1.1 mmol/l versus the expected result 2.59 mmol/l.Non-vitros multichem (lot 15706161) level 2 vitros glu result <1.1 mmol/l versus the expected result 7.23 mmol/l a biased result of the direction and magnitude observed may lead to inappropriate physician action if undetected.The lower than expected vitros glu results were obtained when testing non-vitros quality control samples.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 the event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS 5,1 FS CHEMISTRY 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: 6726327
• MDR Text Key: 80794109
• Report Number: 1319681-2017-00053
• Device Sequence Number: 0
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6801375
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2012
• 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