MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS AMON SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number 1726926

Device Problems High Test Results (2457); Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/08/2020

Event Type  malfunction  

Event Description

The investigation has determined that a higher than expected ammonia (amon) result was obtained from an american proficiency institute proficiency sample and a lower than expected result was obtained from a vitros liquid performance verifier processed using vitros chemistry products amon slides lot 1018-0253-9365 on a vitros 350 chemistry system.Api proficiency sample am-01 result of 103 umol/l vs an expected result of 63.4 umol/l vitros lpv ii lot l7187 result of 159.1 umol/l vs an expected result of 200.5 umol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher than expected vitros amon result was obtained from a proficiency sample and the lower than expected vitros amon result was from a quality control fluid.However, the investigation could not conclude that patient samples were not or would not be affected if the event were to recur undetected.Ortho has not been made aware of any allegation of patient harm as a result of these events.This report is number two of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

Manufacturer Narrative

The investigation has determined that a higher than expected ammonia (amon) result was obtained from an american proficiency institute proficiency sample and a lower than expected result was obtained from a vitros liquid performance verifier processed using vitros chemistry products amon slides lot 1018-0253-9365 on a vitros 350 chemistry system.A definitive assignable cause of the events could not be determined.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros amon reagent lot 1018-0253-9365.A possible cause of the events is an issue related to a suboptimal calibration.The calibration parameters for the calibration event on (b)(6) 2020 were determined to be atypical compared to the database values.The historical quality control results following the calibration event were not acceptable.The higher than expected proficiency sample result was also obtained using the parameters from this calibration event.The cause of the suboptimal calibration is unknown.However, a possible cause of the suboptimal calibration could be related to improper fluid preparation and handling protocol as the customer stated that new technicians had been training around the timeframe of the events and that there were concerns of user error having occurred.Another possible overall cause of the events is user error.The customer stated that at the time of the events, there were concerns of possible improper protocol as new technicians were being trained.Additionally, the customer did not initially report the attainment of the higher than expected proficiency result to ortho as they believed the issue was likely related to user error.As historical qc results were not acceptable a vitros amon lot 1018-0253-9365 related issue cannot be ruled out as a contributing factor of the event.Precision testing was not performed on the vitros 350 chemistry system at the time of the events and historical qc results were imprecise.Therefore, an instrument related issue cannot be confirmed nor ruled out as a contributing factor of the events.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS AMON SLIDES
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• MDR Report Key: 12122704
• MDR Text Key: 281680307
• Report Number: 1319809-2021-00113
• Device Sequence Number: 1
• Product Code: JID
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: 1726926
• Device Lot Number: 1018-0253-9365
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1