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

Catalog Number 1450261

Device Problem High Test Results (2457)

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

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros calcium (ca) results were obtained from a single (b)(6) external quality control (qc) sample processed on a vitros 5,1 fs chemistry system.The assignable cause for this event is unknown, however, the issue is isolated to the affected (b)(6), (b)(6) 2018 sample.The higher than expected vitros ca results obtained were reproducible, indicating a sample related issue.However, 63 of 64 vitros users obtained acceptable results from the same sample, therefore, a sample-matrix issue did not likely contribute to the event.However, a sample related issue isolated to the affected sample at this site cannot be ruled out as contributing to the event.Historical vitros ca qc results and vitros ca within-run precision test results obtained from vitros ca slide lot 0305-0560-5594 tested on the vitros 5,1 fs system were acceptable.This would indicate the vitros 5,1 fs system and vitros ca slide lot 0305-0560-5594 did not malfunction.Additionally, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issues with vitros product ca slide lot 0305-0560-5594.A definitive assignable cause could not be determined.

Event Description

A customer obtained higher than expected vitros calcium (ca) results from a single ((b)(6)) external quality control (qc) sample processed on a vitros 5,1 fs chemistry system.(b)(6) ,(b)(6) 2018 sample vitros ca results of 9.31 and 9.45 mg/dl vs.The expected result of 6.61 mg/dl.Biased results of the direction and magnitude observed may lead to inappropriate physician action if the issue were to occur undetected on patient samples.The higher than expected vitros ca results were obtained when processing a qc fluid.There was no indication from the customer that vitros ca patient results were questioned by clinicians.However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There was no allegation of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CA SLIDES
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: 8184352
• MDR Text Key: 131921936
• Report Number: 1319809-2018-00169
• Device Sequence Number: 1
• Product Code: CJY
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2019
• Device Catalogue Number: 1450261
• Device Lot Number: 0305-0560-5594
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2017
• 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