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

Catalog Number 1726926

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/12/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros amon results were obtained when the customer processed a non-vitros biorad quality control (qc) fluid using vitros amon lot 1018-0255-4508 on a vitros 5600 integrated system.The assignable cause of the event cannot be determined with the information provided.Historical qc for vitros amon lot 1018-0255-4508 was unacceptable, however a complaint review for vitros amon lot 1018-0255-4508 indicated only one additional complaint that was resolved by service actions.Continual tracking and trending does not indicate a systemic issue with vitros amon lot 1018-0255-4508.A diagnostic vitros amon precision test was requested by the tsc but not completed by the customer at the time of this report.Therefore, an issue with the vitros 5600 integrated system cannot be ruled out as a contributor to the event.Email address for contact office is (b)(6).

Event Description

The investigation determined that higher than expected vitros ammonia (amon) results were obtained when the customer processed a non-vitros biorad quality control (qc) fluid using vitros amon lot 1018-0255-4508 on a vitros 5600 integrated system.Biorad lot 54302 vitros amon results of 108.4, 104.4, 108.9, 118.5, 92.1, 99.5 and 90.4 umol/l versus the baseline mean of 74.76 umol/l.The customer obtained the lower than expected result when processing a non-patient fluid.There was no indication patient results were affected around the time of the event.However, the investigation could not rule out patient samples would not be affected if the event were to recur undetected.Ortho was not made aware of any allegation of patient harm as a result of this event.This report is number five of seven mdr¿s for this event.Seven 3500a forms are being submitted for this event as seven devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and ivd (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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 11812991
• MDR Text Key: 276226562
• Report Number: 1319809-2021-00081
• 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: Other
• Type of Report: Initial
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Catalogue Number: 1726926
• Device Lot Number: 1018-0255-4508
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2020
• 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