MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HIV DUO ELECSYS E2G; HIV DETECTION TEST

Catalog Number 07229542190

Device Problem Non Reproducible Results (4029)

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

Event Date 02/18/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi): (b)(4).Sample material was requested for investigation.The investigation is ongoing.

Event Description

The initial reporter questioned results for 1 patient sample tested for elecsys hiv duo ((b)(6)) on a cobas e801 module.The initial result from the primary tube on the customer's e801 module was (b)(6).The repeat result from an aliquot on the customer's e801 module was (b)(6).The customer performed liquid flow cleaning and calibrated a new reagent with the same lot number; the result from a different tube obtained at the same time run on the customer's e801 module was (b)(6).An aliquot sample was tested on a competitor instrument and the result was (b)(6).The actual result was not provided.The customer then sent an aliquot sample to another laboratory using an e801 module and the result was (b)(6).The actual result was not provided.The customer re-centrifuged the sample and repeated it on their e801 module, but the result was still (b)(6).The actual result was not provided.The field service engineer (fse) cleaned the pre-wash sippers of the rinse station.The customer ran the sample on a different measuring cell of the instrument and re-calibrated the reagent but the patient sample was still (b)(6).The actual result was not provided.During the week of (b)(6) 2021, a new sample was obtained from the patient and the (b)(6) result was still (b)(6) on the customer¿s e801 module.The actual result was not provided.The customer thinks the patient should have a (b)(6) result based on the patient¿s age and the results from the other instruments.It is not clear which results are correct as no pcr confirmation testing was performed.No questionable results were reported outside of the laboratory.The e801 module serial number was (b)(4).

Manufacturer Narrative

Calibration and qc were acceptable.Two samples from the patient were submitted for investigation.The samples showed elevated, but negative hiv duo results.The elevated results are caused by a slight reaction in the hiv module of the hiv duo assay.All initially reactive or borderline samples should be re-determined in duplicate with the elecsys hiv duo assay.If cutoff index values < 1.00 are found in both cases, the samples are considered negative for hiv-1 ag and hiv-1/-2 specific antibodies.Initially reactive or borderline samples giving cutoff index values of = 1.0 in either of the redeterminations are considered repeatedly reactive.Repeatedly reactive samples must be confirmed according to recommended confirmatory algorithms.Confirmatory tests include western blot and/or hiv rna tests.Based on the investigation results, the patient is negative for hiv.The reagent performs within specification.The investigation did not identify a product problem.

• Brand Name: HIV DUO ELECSYS E2G
• Type of Device: HIV DETECTION TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11517247
• MDR Text Key: 269645538
• Report Number: 1823260-2021-00847
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• PMA/PMN Number: BP190403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

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: 06/30/2021
• Device Catalogue Number: 07229542190
• Device Lot Number: 483078
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR