MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTICS PRODUCT ANTI-HIV1+2 REAGENT; IN VITRO DIAGNOSTIC

Catalog Number 6801861

Device Problem False Negative Result (1225)

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

Event Date 03/03/2014

Event Type  malfunction  

Event Description

The customer obtained repeatable, (b)(6) vitros anti-hiv1+2 results from a single patient sample on a vitros 5600 integrated systems when compared to a single (b)(6) result obtained using a non ocd roche hiv combo assay.Biased results of the direction and magnitude observed could lead to inappropriate physician action.It is unknown if the (b)(6) vitros anti-hiv1+2 result was reported outside of the laboratory.There was no report of patient harm as a result of this event.(b)(4).

Manufacturer Narrative

Repeatable (b)(6) vitros ahiv 1+2 results were obtained from a patient sample compared to a single (b)(6) result obtained using a non ocd roche hiv combo assy.The event was isolated to a single patient sample.A review of the customer¿s vitros 5600 instrument data logs did not reveal any instrument issue that may have contributed to the event.The vitros ahiv 1+2 assay can only detect the presence of antibody to (b)(6) in a sample.Only a single qualitative (b)(6) roche hiv assay result was provided, and the roche assay is capable of detecting both antibody to (b)(6).However, because of the roche hiv combo method (b)(6) result, it is possible antibody to (b)(6) is present in the sample; therefore ocd will conservatively report this event to regulatory authorities as a (b)(6) vitros ahiv 1+2 event.The customer made no allegation that inappropriate medical action was taken resulting in actual or potential harm to the patient.

• Brand Name: VITROS IMMUNODIAGNOSTICS PRODUCT ANTI-HIV1+2 REAGENT
• Type of Device: IN VITRO DIAGNOSTIC
• 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: 3878131
• MDR Text Key: 4589423
• Report Number: 3007111389-2014-00126
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2014

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: 07/04/2014
• Device Catalogue Number: 6801861
• Device Lot Number: 3130
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2014
• Initial Date FDA Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1