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

Catalog Number 1632660

Device Problem Low Test Results (2458)

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

Event Date 07/06/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros lithium (li) results were obtained from vitros performance verifier quality control fluids and two patient samples processed using vitros li slide lot 3128-0120-2296 on a vitros xt 7600 integrated system.The investigation determined the assignable cause of this event was due to a non-reactive cartridge, where the integrity of the foil wrapper was compromised, exposing the slides to ambient conditions.The lower than expected vitros li results were isolated to a single slide cartridge.The event is consistent with a slide cartridge that has been exposed to ambient conditions.Acceptable vitros li results were obtained from the cartridges in use prior to the affected cartridge and using an alternate slide cartridge (same lot) after the effected slide cartridge was unloaded from the instrument.The customer inspected the cartridge foil wrapper and identified a puncture.The cause of the puncture in the foil wrapper was not determined.(b)(4).

Event Description

The investigation determined that lower than expected vitros lithium (li) results were obtained from vitros performance verifier (pv) quality control fluids and two patient samples processed using vitros li slide lot 3128-0120-2296 on a vitros xt 7600 integrated system.(b)(6).Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.Negatively biased li results were reported outside of the laboratory for the two patient samples; however, li testing was repeated using a new vitros li slide cartridge from the same lot and corrected reports were issued.There were no allegations of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS LI 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 12245171
• MDR Text Key: 266179815
• Report Number: 1319809-2021-00122
• Device Sequence Number: 1
• Product Code: JIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: 1632660
• Device Lot Number: 3128-0120-2296
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1