MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK; IN-VITRO DIAGNOSTICS

Model Number 6802892

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 10/18/2022

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower and higher than expected vitros intact pth (ipth) results were obtained when non-vitros biorad quality control (qc) fluids were processed using vitros ipth reagent lots 1605 and 1621 when tested on a vitros 5600 integrated system.Vitros ipth lot 1605 biorad level 3 lot 64930 result of 778.0, 783.8, 777.2, 766.5 and 765.1 pg/ml versus the expected result of 585.3 pg/ml vitros ipth lot 1621 biorad level 1 lot 64930 result of 15.95, 15.40, 16.12, 15.00, 16.43, 16.74, 15.88, 16.65, 16.52, 15.17, 14.99 and 15.41 pg/ml versus the expected result of 26.05 pg/ml 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 ipth results obtained were not reported outside of the laboratory and there was no reported allegation of patient harm as a result of this event.This report is number one of four mdr¿s for this event.Four 3500a forms are being submitted for this event as four devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint (b)(4).

Manufacturer Narrative

The investigation has determined that lower and higher than expected vitros intact pth (ipth) results were obtained when non-vitros biorad quality control (qc) fluids were processed using vitros ipth reagent lots 1605 and 1621 when tested on a vitros 5600 integrated system.A definitive assignable cause could not be determined for the higher than expected biorad qc results obtained from ipth lot 1605.It is possible that the biorad baseline mean in use was not appropriate for lot 1605 but there was no peer data for comparison to confirm ipth qc performance.The customer did not report any concern with patient accuracy using lot 1605.A definitive assignable cause could not be determined for the lower than expected biorad qc results obtained from ipth lot 1621.A patient comparison was performed between the two ipth lots and the lot 1621 results were lower than the lot 1605 results.The customer deemed the comparison acceptable based on acceptable results obtained from vitros ipth qc results.Ortho has initiated an investigation for lower than expected results obtained from multiple vitros ipth reagent lots tested on multiple vitros instrument platforms.An instrument related performance issue was not a likely contributor to the event as the customer gave no indication of any instrument malfunction.However, as no testing was performed to confirm the vitros 5600 instrument performance, an instrument issue cannot be completely ruled out.Ortho has initiated an investigation for lower than expected results obtained from multiple vitros ipth reagent lots tested on multiple vitros instrument platforms.

Manufacturer Narrative

This supplemental mdr was created to update the root cause for the lower than expected vitros ipth results.Ortho's investigation has identified the root cause of this issue stems from a raw material used in the affected lots.A communication ((b)(4)) was sent on 17 november 2022 to all customers who have been shipped vitros ipth reagent pack within the previous 12 months.The communication informed customers that when performing patient sample testing using the affected ipth lots (1610, 1621, 1630, 1640, 1645, 1650, 1670), customers may experience an average negative bias of approximately -12%.In addition, a variable negative shift in performance was also confirmed using biorad liquicheck/lyphocheck specialty immunoassay controls and thermo scientific mas omni immune immunoassay controls when compared to their published assigned values.Ortho has assigned new mean and sd values for available biorad and thermo fisher control lots for use specifically with the affected lots listed in the communication.The fda was notified of this issue on 17 november 2022.Please refer to report #3007111389-11/17/2022-001-c.

Event Description

This supplemental mdr was created to update the root cause of the lower than expected vitros ipth results.In addition, the ipth issue was reported as a class ii recall and a communication was sent to customers.This report is number one of four mdr¿s for this event.Four 3500a forms were submitted for this event as four devices were involved.However, device four for this event was for an ipth lot not associated with the recall, and therefore no supplemental mdr will be submitted for device four for this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) , (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 15847967
• MDR Text Key: 307994719
• Report Number: 3007111389-2022-00606
• Device Sequence Number: 1
• Product Code: CEW
• UDI-Device Identifier: 10758750006267
• UDI-Public: 10758750006267
• 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 Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2023
• Device Model Number: 6802892
• Device Catalogue Number: 6802892
• Device Lot Number: 1621
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1