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

Catalog Number 1721869

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation concluded that a higher than expected result was obtained from a single patient sample using vitros amon micro slides on a vitros 5600 integrated system. The investigation could not determine the assignable cause of the event. The samples were processed within 12 minutes on both systems; therefore, improper pre-analytical sample handing did not likely contribute to the event. There were no historical quality control results available to access the performance of the amon lot on the affected vitros 5600 system. However, ongoing tracking and trending of complaints has not identified any signals that would suggest there is a systemic issue with vitros amon reagent lot 1017-0248-5923. A vitros amon within-run precision test was acceptable for both accuracy and precision, indicating an analyzer related issue did not likely contribute to the event. However, only a single level of quality control was processed for the precision test, and it is unknown if the calibration in use was acceptable across the amon measuring range. Therefore, it is possible the event was due to calibration to calibration variation.

Event Description

A customer reported unexpected results obtained from a patient sample correlation performed between two different vitros 5600 integrated systems using vitros clinical chemistry products ammonia (amon) slides. Patient sample result of 94 umol/l vs. The expected result of 77 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 patient sample result was not reported outside of the laboratory and there was no allegation of patient harm. This report corresponds to ortho clinical diagnostics inc. (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: 7967333
• MDR Text Key: 126114926
• Report Number: 1319809-2018-00113
• 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: 10/15/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/01/2019
• Device Catalogue Number: 1721869
• Device Lot Number: 1017-0248-5923
• 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: 09/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage