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

Catalog Number 1726926

Device Problem High Readings (2459)

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

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a higher than expected amon (ammonia) result was obtained from a non-vitros (mas) quality control (qc) fluid when tested using vitros amon lot 1018-0254-2654 on a vitros 5600 integrated system. A definitive assignable cause could not be determined at the time of this report. However, the most likely assignable cause of the event is an instrument related issue. Precision testing and historical qc results were imprecise and were not within acceptable guidelines. After service actions were performed by an ortho field engineer (fe) which included decontaminating the cm/rt ring, replacing the microslide metering pump, and replacing a humidity cartridge to repair a humidity cover plate air leak, post-service vitros amon precision testing was conducted which yielded results that were not within ortho acceptable guidelines. Prior to service, the customer had reported that the evaporation caps were dirty. It is unknown if the customer cleaned or replaced the evaporation caps. The most likely cause of the event is an instrument related issue, however, because service did not resolve the issue, an instrument related issue cannot be confirmed. At the time of this report, another visit to the site for the fe was scheduled by the tsc along with recommendations to complete the full microslide incubator ammonia decontamination procedure on the vitros 5600 system. In addition, an issue related to the use of ammonia based cleaning products could not be entirely confirmed nor ruled out as a possible contributor of the event as the customer confirmed that no such products had been used on the vitros 5600 system, however, could not confirm whether such products had been used in the laboratory around the instrument. A vitros amon reagent lot 1018-0254-2654 related issue is not a likely contributor of the event as unexpected results had also been obtained on the vitros 5600 integrated system using an alternate lot of vitros amon reagent. However, as a definitive cause was not established, a reagent related issue could not be entirely ruled out. However, 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 1018-0254-2654. Email address for contact office is (b)(4).

Event Description

A customer obtained a higher than expected amon (ammonia) result from a non-vitros (mas) quality control (qc) fluid when tested using vitros amon lot 1018-0254-2654 on a vitros 5600 integrated system. Mas lot aa22022a, vitros amon result of 237. 6 umol/l vs the expected result of 164. 0 umol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected. The higher than expected vitros amon result was obtained when processing a control fluid. No results were reported out of the laboratory. 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 reported allegation of actual patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc (ortho). Complaint numbers (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS AMON SLIDES
• Type of Device: IN-VITRO DIAGNOSTIC
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: laurie o'riordan ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 11373435
• MDR Text Key: 262927534
• Report Number: 1319809-2021-00014
• Device Sequence Number: 1
• Product Code: JID
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/24/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/01/2022
• Device Catalogue Number: 1726926
• Device Lot Number: 1018-0254-2654
• Was Device Available for Evaluation?: Yes

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage