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

Catalog Number 6802893

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

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

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that both lower and higher than expected vitros ipth results were obtained from three levels of non-vitros biorad lot 64910 control fluids processed using the in-use vitros ipth reagent lot 1210 on a vitros 5600 integrated system the most likely assignable cause of the event was the (b)(6) 2020 calibration and the (b)(6) 2020 calibration in use at the time of the events.The qc results following each calibration event were unacceptable indicating that while both calibrations passed they were likely suboptimal.The vitros ipth calibrators are lyophilized and require reconstitution with 1.0 ml of distilled water.No information was provided concerning the reconstitution, fluid handling and storage protocols of the lot 1210 calibrators used for the affected calibrations, therefore, improper calibrator fluid handling cannot be ruled out as contributing to the event.In addition, multiple improper protocol issues may be contributing to the event.At the same time that this event occurred with the vitros ipth assay, the customer reported higher than expected quality control results were obtained from multiple vitros microslide assays and the vitros hba1c microtip assay.An ortho laboratory specialist (ls) went on site on (b)(4) 2020 and concluded the issue was likely due to protocol issues related to fluid handling.There is no indication an instrument related issue contributed to the event, however, an instrument related issue cannot be completely ruled out as no diagnostic within-run precision testing was performed to assess the performance of the vitros 5600 system.Finally, vitros ipth reagent lot 1210 cannot be completely ruled out as contributing to the event as the historical quality control results were not acceptable since the reagent lot was put into use.However, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros ipth reagent lot 1210.(b)(4).

Event Description

The customer reported that both lower and higher than expected results from were obtained from three levels of non-vitros biorad lot 64910 control fluids processed using the in-use vitros ipth reagent lot 1210 on a vitros 5600 integrated system.All the lower than expected results were associated with a calibration event that occurred on (b)(6) 2020 and all the higher than expected results were associated with a calibration event that occurred on (b)(6) 2020.On (b)(6) 2020 calibration result biorad l2 = 119.4, 113.6, 116.3, 126.0, 126.5, 122.9, 124.7, 121.3, 121.1, 120.0, 120.7, 120.4, and 120.0 pg/ml vs.The expected result of 183.2 pg/ml.Biorad l3 = 426.3, 428.9, and 415.3 pg/ml vs.The expected result of 614.9 pg/ml.On (b)(6) 2020 calibration result biorad l1 = 37.2 and 36.9 pg/ml vs.The expected result of 20.9 pg/ml.Biorad l2 = 372.9 pg/ml vs.The expected result of 183.2 pg/ml.Biorad l3 = 1201.6, and 1182.4 pg/ml vs.The expected result of 614.9 pg/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower 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 two different calibration events were affected.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: 10881448
• MDR Text Key: 225609692
• Report Number: 3007111389-2020-00187
• 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: 11/20/2020

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: 01/11/2021
• Device Catalogue Number: 6802893
• Device Lot Number: 1210
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2020
• 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