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

Catalog Number 6802220

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported a higher than expected vitros bhcg result on a single non-vitros biorad l1 compared to the vitros peer mean tested on a vitros 5600 integrated system.The assignable cause of the event is unknown.Improper sample handling cannot be ruled out as contributing to the event.It is possible the customer left the uncapped l1 control fluid on board the vitros instrument for >1 hour, although this cannot be confirmed.A vitros bhcg reagent related issue cannot be ruled out as there were insufficient data points to adequately assess vitros bhcg reagent lot 2680.In addition, a vitros instrument related issue did not likely contribute to the event as a vitros bhcg within-run precision test indicated vitros bhcg reagent lot 2680 was performing as expected on the vitros 5600 system.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report higher than expected vitros total b-hcg ii (bhcg) results were obtained from a non-vitros seqc proficiency fluid tested on a vitros 5600 system.Biorad l1 bhcg result of 8.54 miu/ml vs the vitros peer mean result of 5.40 miu/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The customer made no allegation that erroneous patient results had been predicted or reported from the laboratory.There is no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B HCG II 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: 10471345
• MDR Text Key: 244361370
• Report Number: 3007111389-2020-00113
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2020

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: 02/09/2021
• Device Catalogue Number: 6802220
• Device Lot Number: 2680
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2020
• 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