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

Catalog Number 6802413

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/04/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that 45 higher than expected amon results were obtained from both ortho and non-ortho biorad quality control fluids on a vitros 5600 integrated system the most likely assignable cause is an instrument issue related to incubator contamination based on pre-service within run precision testing performance higher than the guideline and acceptable post-service precision.An ortho field engineer performed service actions on the microslide incubator and replaced the evaporation caps, belt and wear pads.Following completion of maintenance actions significantly improved vitros amon precision performance was achieved using the same vitros amon reagent lot.

Event Description

A customer obtained 45 higher than expected vitros amon results from ortho and non-ortho biorad quality control fluids using vitros amon slide lot 1014-0239-3216 tested on a vitros 5600 integrated system.Vitros lpv i results of 90.7 umol/l compared to an expected result of 45.1 umol/l.Vitros lpv ii result of 256.3 umol/l compared to an expected result of 199.2 umol/l.Biorad liquicheck quality control fluid (lot#51962) results of 129.6, 126.5, 126.1, 123, 122.2, 121.4, 121.4, 121.2, 120.1, 119.7, 118.1, 117.7, 116.1, 115.7, 112.7, 111.2, 111, 108.9, 100.4, 99.1, 99, 98.8, 97.3, 97.1, 115.3, 131.4, 128.1, 127, 122.1, 121, 120, 119.5, 119.2, 118.7, 115.1, 114.9, 110.1, 106.6, 105.2, 103, 100.3, 99.3, 96.2 umol/l compared to an expected result of 80 umol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected.Ortho has not been made aware of any erroneous vitros amon results obtained or reported from the laboratory during the time frame of this event.However, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected.There was no allegation of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics (ortho) inc.Complaint numbers (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: 5485394
• MDR Text Key: 40080905
• Report Number: 1319681-2016-00042
• 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: 03/08/2016

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: 02/11/2016
• Initial Date FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2014
• 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