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

Model Number 6802892

Device Problem Low Test Results (2458)

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

Event Date 10/30/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that lower-than-expected vitros intact pth (ipth) results were obtained from non-vitros biorad quality control (qc) fluid when using a vitros immunodiagnostic products intact pth (ipth) reagent on two different vitros xt 7600 integrated systems.A definitive assignable cause could not be determined with the information provided.An instrument related performance issue did not likely contribute to the event as the customer gave no indication of any instrument malfunction and acceptable results were obtained using alternate vitros ipth reagent lots without performing any actions to the vitros xt 7600 integrated system.Ortho has initiated an investigation for lower than expected results obtained from multiple vitros ipth reagent lots tested on multiple vitros instrument platforms.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros intact pth (ipth) results were obtained from non-vitros biorad quality control (qc) fluid when using a vitros immunodiagnostic products intact pth (ipth) reagent on two different vitros xt 7600 integrated systems.Biorad lot 64940 level 1 result of 14.3, 13.86, 14.10, 14.27, 14.34, 14.67, and 16.41 pg/ml vs an expected result of 23.79 pg/ml biorad lot 64940 level 2 result of 139.37, 134.31, 134,45 and 136.04 pg/ml vs an expected result of 224.48 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 than expected results were obtained from non-patient fluids.There was no indication that patient samples were affected around the time of the event, there was no allegation of patient harm as a result of this event.This report is number one of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4), (b)(4) and reportability assessment 600074.

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 (cl2022-275) 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 two supplemental mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment 600074.

• 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: 15846223
• MDR Text Key: 308002608
• Report Number: 3007111389-2022-00635
• 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: Recall
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

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: 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
• Initial Date Manufacturer Received: 10/30/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 10/30/2022
• Supplement Dates FDA Received: 12/01/2022
• 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