MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK; IN VITRO DIAGNOSTICS

Catalog Number 6801756

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that lower than expected vitros tsh and psa results were obtained from multiple patient samples and quality control fluids tested on a vitros eciq immunodiagnostic system.An ortho laboratory specialist (ls) performed precision and accuracy studies by processing patient samples and quality control fluids without calibrating the assays post service actions.The ortho ls did not realize the qc results were out of range prior to running the patient samples.Once the ls noticed the qc results were unacceptable, she recalibrated the assays to resolve the issue.The assignable cause of the results obtained post service/before recalibration were concluded to be user error with not calibrating following significant service actions performed by an ortho field engineer.In the vitros eci/eciq operators guide it specifically states that you may need to perform calibration after service procedures are performed.The assignable cause of the data points obtained post service/post recalibration (tsh 3.31, 5.72 miu/l; psa 1.57, 9.36, 14.4 ng/ml) was unknown as the customer accepted the results and no further investigation was performed.

Event Description

An ortho clinical diagnostics (ortho) laboratory specialist (ls) contacted the technical solutions center (tsc) to report a lower than expected tsh and psa results obtained from quality control (qc) fluids and patient samples processed using vitros tsh and psa reagent on a vitros eciq immunodiagnostics system.Vitros psa lot 3840: sample (b)(6) = 1.12, 1.57 versus expected 2.17 ng/ml.Sample (b)(6) = 2.0 versus expected 3.23 ng/ml.Sample (b)(6) = 6.41, 9.36 versus expected 12.94 ng/ml.Sample (b)(6) = 0.992 versus expected 1.54 ng/ml.Sample (b)(6) = 9.88, 14.4 versus expected 32.62 ng/ml.Sample (b)(6) = 2.48 versus expected 3.52 ng/ml.Biorad level 3 = 8.79 versus expected 13.9 ng/ml.Vitros tsh lot 6170: sample (b)(6) = 3.4 versus expected 5.04 miu/l.Sample (b)(6) = 0.503 versus expected 0.997 miu/l.Sample (b)(6) = 3.11 versus expected 4.5 miu/l.Sample (b)(6) = 2.37 versus expected 3.6 miu/l.Sample (b)(6) = 0.814 versus expected 1.28 miu/l.Sample (b)(6) = 50.7 versus expected >100 miu/l.Sample (b)(6) = 9.95 versus expected 17.67 miu/l.Biorad level 1 = 0.198 versus expected 0.307 miu/l.Biorad level 3 = 19.3 versus expected 29.3 miu/l.Sample (b)(6) = 3.31 versus expected 2.42 miu/l.Sample (b)(6) = 5.72 versus expected 3.94 miu/l.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 vitros tsh and psa results obtained were part of a method comparison study and were not reported from the laboratory.There were no allegations of patient harm as a result of this event.This report is number 2 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.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK
• 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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10220932
• MDR Text Key: 230615574
• Report Number: 3007111389-2020-00068
• Device Sequence Number: 1
• Product Code: LTJ
• 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: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2020
• Device Catalogue Number: 6801756
• Device Lot Number: 3840
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2020
• 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