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

Catalog Number 1726926

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher and lower than expected vitros amon results were obtained when processing royal college of pathologists of australasia (rcpaqap) proficiency fluids using vitros chemistry products ammonia (amon) slides on a vitros 5,1 fs chemistry system.The definitive assignable cause could not be determined.A precision test was not processed and therefore, an analyzer related issue caused by microslide incubator contamination cannot be ruled out as a potential cause.Historical quality control (qc) results are acceptable for one set of qc provided, but are unacceptable for the level ii fluid for the other two sets of qc provided.It is unknown which reagent lot number was run with each set of qc.An issue with vitros amon lots 1018-0250-3870, 1018-0250-1827, 1018-0250-1816, 1018-0250-1814 and 1018-0249-0347 could not be confirmed or ruled out as a contributor of the event.However, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros amon reagent lots 1018-0250-3870, 1018-0250-1827, 1018-0250-1816, 1018-0250-1814 or 1018-0249-0347.It is unknown when any of the vitros amon lots listed in the complaint description were put into use, or what lot of vitros amon the customer processed the proficiency samples on.Therefore, a device count of 5 for the 5 slide lots in use will be reported.

Event Description

A customer reported imprecise vitros amon results obtained from proficiency fluids using vitros chemistry products ammonia (amon) slides in combination with a vitros 5,1 fs chemistry system.Rcpaqap proficiency fluid 39-01 result of 204 mol/l versus vitros peer mean result of 267 mol/l rcpaqap proficiency fluid 39-03 result of 88 mol/l versus vitros peer mean result of 119 mol/l rcpaqap proficiency fluid 39-04 result of 132 mol/l versus vitros peer mean result of 169 mol/l rcpaqap proficiency fluid 39-07 result of 92 mol/l versus vitros peer mean result of 118 mol/l rcpaqap proficiency fluid 39-09 result of 45 mol/l versus vitros peer mean result of 265 mol/l rcpaqap proficiency fluid 39-10 result of 223 mol/l versus vitros peer mean result of 69 mol/l rcpaqap proficiency fluid 40-04 result of 85 mol/l versus vitros peer mean result of 118 mol/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 lower and higher than expected vitros amon results were obtained when processing unknown external proficiency fluids.However, the investigation cannot conclude that patient sample results were not affected or 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 3 of 5 mdr¿s for this event.Five (5) 3500a forms are being submitted for this event as 5 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (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: 9188394
• MDR Text Key: 214614216
• Report Number: 1319809-2019-00098
• Device Sequence Number: 1
• Product Code: JID
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Catalogue Number: 1726926
• Device Lot Number: 1018-0250-1816
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2018
• 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