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 07/10/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation confirmed that unexpected vitros amon results were obtained using a single level of non-vitros biorad quality control and a single level of vitros quality control using two different vitros amon slide lots tested on two different vitros 5600 integrated systems.The investigation concludes that the phs event that occurred on vitros j56000563 was most likely an instrument related issue and was resolved by service actions.The customer observed non-reproducible results initially on amon slide lot 1017-0245-8847.The customer then calibrated alternate amon lot 1017-0245-0209 and the quality control results post calibration were still unacceptable.The same vitros lpv and biorad quality control fluids were acceptable on an alternate analyzer after calibration of the alternate amon lot indicating that the qc fluids themselves are not a likely contributor to the event.An ortho fe performed service actions to the reflectometer subsystem which include replacing mirror/lens, lamp and lamp assembly on vitros j563 analyzer.It was confirmed that acceptable amon qc results have been maintained following service actions.The assignable cause for the event that occurred on vitros j56000562 is unknown.The inventory of vitros amon lot 1017-0245-8847 was depleted and therefore, it was not possible to further investigate that slide lot.The customer performed no troubleshooting actions other than calibration of an alternate amon slide lot 1017-0245-0209 and acceptable quality control results post calibration were obtained.There was no indication of an instrument malfunction.

Event Description

The investigation determined unexpected ammonia results were obtained from a single level of non-vitros biorad quality control and a single level of a vitros quality control fluid when using two different vitros amon slide lots on two different vitros 5600 integrated systems.J56000563 with amon lot 1017 0245 8847, biorad level 3 lot 51990 = 159.05, 164.63, 157.43 versus expected 216.5 umol/l, lpv ii lot x5010= 101.66 versus expected 169.5 umol/l.J56000563 with amon slide lot 1017 0245 0209, biorad level 3lot 51990= 170.7 versus expected 216.5 umol/l.Lpv ii lot x5010= 120.9 versus expected 169.5 umol/l.J56000562 with amon lot 1017 0245 8847, biorad level 3 lot 51990= 169.915 versus expected 216.5 umol/l, lpv ii lot x5010= 113.641, 117.47 versus expected 169.5 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 did not process patient samples as the quality control results were not acceptable, however the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There was no reported allegation of patient harm as a result of this event.This report is number one of four 3500a forms filed for this event, as four devices were affected.This report corresponds to ortho clinical diagnostics inc.Complaint number (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: 6751809
• MDR Text Key: 81420929
• Report Number: 1319681-2017-00060
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• 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?: Yes
• Date Manufacturer Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2009
• 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