MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B HCG II CALIBRATORS; IN-VITRO DIAGNOSTICS

Catalog Number 6802221

Device Problem High Test Results (2457)

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

Event Date 08/29/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected total b-hcg ii (bhcg) results were obtained from a non-vitros biorad quality control (qc) fluid using vitros immunodiagnostics products total bhcg ii reagent lot 3441 in combination with a vitros 5600 integrated system.The assignable cause for the higher than expected vitros bhcg qc fluid results is suboptimal calibrations.The parameters for all the calibration events that occurred from (b)(6) 2022 were atypical when compared to database values.The cause of the suboptimal calibrations is unknown.After restoring the calibration event from 25 (b)(6) 2022, vitros bhcg lot 3441 qc results returned to expectation.Based on acceptable historical quality control results, a vitros bhcg lot 3441 performance issue is not a likely contributor to the event.Additionally, although there was no diagnostic precision testing run on the vitros 5600 system, an instrument issue is not a likely contributor to the event as acceptable results were obtained before and after the atypical calibration events with no actions performed on the analyzer.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros bhcg ii reagent lot 3441.Email address for contact office above is (b)(6).

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected b-hcg ii (bhcg) results were obtained from a non-vitros biorad quality control (qc) fluid using vitros immunodiagnostics products total bhcg ii reagent lot 3441 in combination with a vitros 5600 integrated system.Biorad lot 85210 level 1 vitros bhcg results of 9.8, 10.4, 14.8, 10.0 and 9.2 miu/ml versus an expected result of 6.12 miu/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 higher than expected vitros bhcg results were from a non-patient fluid.The customer did not give any indication that patient results had been affected.There is no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B HCG II 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 15506058
• MDR Text Key: 306273017
• Report Number: 3007111389-2022-00092
• 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: 09/28/2022

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: 03/26/2023
• Device Catalogue Number: 6802221
• Device Lot Number: 3441
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: N/A.