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

Catalog Number 1726926

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation concluded that a higher than expected vitros chemistry products ammonia (amon) result was obtained from an american proficiency institute (api) sample using vitros amon slides on a vitros 350 chemistry system. The customer was unable to provide the exact date the api samples were tested, the vitros amon slide lot in use when the api samples were tested, or any historic quality control results that were generated during the timeframe that the api samples were processed in (b)(6) 2018. Therefore, the cause of the higher than expected vitros amon result obtained from api sample am-06 cannot be determined. An instrument, reagent, or sample handling issue cannot be ruled out as possible causes of the event.

Event Description

A customer reported a higher than expected result obtained from an american proficiency institute (api) sample using vitros chemistry products amon slides on a vitros 350 chemistry system. Api am-06 proficiency sample vitros amon result of 270 umol/l vs. The expected result of 218. 8 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 when processing api fluids. There was no report of affected patient results, 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 were no allegations of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. Complaint number (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
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 8711461
• MDR Text Key: 212154901
• Report Number: 1319809-2019-00043
• Device Sequence Number: 1
• Product Code: JID
• 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

• Type of Report: Initial
• Report Date: 06/19/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/01/2020
• Device Catalogue Number: 1726926
• Device Lot Number: 1018-0250-3889
• Was Device Available for Evaluation?: No Answer Provided

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage