MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH CALIBRATORS; IN VITRO DIAGNOSTICS

Catalog Number 6802893

Device Problem High Test Results (2457)

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

Event Date 10/10/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros ipth results were obtained from a single level of non-vitros level 3 (l3) biorad control fluid using two different vitros ipth reagent lots on two different vitros 5600 systems.The assignable cause of the events was the vitros ipth calibration in use.For vitros ipth lot 1300, the affected results from both instruments were obtained following a calibration event performed on (b)(6) 2020.Acceptable vitros ipth performance was obtained after both vitros 5600 systems were calibrated using a new set of vitros lot 1300 calibrator fluids.The cause of the sub-optimal calibration was not determined.For vitros ipth lot 1201, the affected results from were obtained following a calibration event performed on (b)(6) 2020.The customer discontinued use of vitros ipth reagent lot 1201 and therefore no further investigation was performed.The cause of the sub-optimal calibration was not determined.No information was provided concerning the fluid handling and storage protocols of the lot 1201 or lot 1300 calibrators used for the affected calibrations, therefore, improper calibrator fluid handling cannot be ruled out as contributing to the event.(b)(4).

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical service center (tsc) to report higher than expected intact pth (ipth) results that were obtained from a single level of non-vitros level 3 (l3) biorad lot 64910 quality control fluid on two vitros ipth reagent lots tested on two different vitros 5600 integrated systems.Vitros ipth reagent, lot 1300 with vitros 5600 #1.Vitros l3 results of 1178.8, 1139.7, 1156.9 and 1143.8 pg/ml vs.The expected result of 663.0 pg/ml.Vitros ipth reagent, lot 1300 with vitros 5600 #2.Vitros l3 result of 1156.2 pg/ml vs.The expected result of 663.0 pg/ml.Vitros ipth reagent, lot 1201 with vitros 5600 #1.Vitros l3 results of 867.8, 884.3, and 879.5 pg/ml vs.The expected result of 663.0 pg/ml.Biased results of magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected results were obtained from non-patient quality control samples.The customer did not indicate that patient samples were affected and there is no allegation of patient harm.This report is number 1 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH CALIBRATORS
• 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; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: joseph falvo ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10871130
• MDR Text Key: 252295594
• Report Number: 3007111389-2020-00185
• Device Sequence Number: 1
• Product Code: JIT
• 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: 11/19/2020

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: 12/21/2020
• Device Catalogue Number: 6802893
• Device Lot Number: 1201
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2020
• 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