MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HIV COMBI PT; HIV DETECTION TEST

Model Number HIV COMBI

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer's calibration and qc data were acceptable.The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys (b)(6) combi pt results for one patient tested on a cobas 6000 e 601 module.The e 601 serial number was requested but not provided.No questionable results were reported outside the laboratory.The patient¿s sample was collected on (b)(6) 2020 and was tested with the hiv duo elecsys e2g assay.The patient¿s (b)(6) duo results were from a cobas 8000 e 801 module.The customer used the same patient sample for repeat testing on (b)(6) 2020.On (b)(6) 2020, the patient¿s (b)(6) duo result was reactive.On (b)(6) 2020, the patient¿s (b)(6) duo result was reactive.On (b)(6) 2020, the patient¿s (b)(6) combi result was 0.331 coi non-reactive.The customer could not confirm which result is correct for the patient.

Manufacturer Narrative

The customer's provided calibration data and qc data were acceptable.The customer provided the patient's sample for investigation.The investigation reproduced the customer's results.The investigation performed an elecsys hiv ag confirmatory test with the patient's sample, and the patient's result was negative.The investigation confirmed the customer's hiv combi result of 0.331 coi non-reactive was correct for the patient.The investigation determined the patient's sample was reactive with monoclonal antibodies of the hivag detection module of the hiv duo elecsys e2g assay.The product labeling states, "specimens from patients who have received mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies and may interfere in assays that employ mouse monoclonal antibodies." per product labeling, for reactive sample results using the elecsys hiv duo assay, "all initially reactive samples should be redetermined in duplicate with the elecsys hiv duo assay." also, "repeatedly reactive samples must be confirmed according to cdc recommended confirmatory algorithms." the investigation did not identify a product problem.

• Brand Name: ELECSYS HIV COMBI PT
• Type of Device: HIV DETECTION TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10868814
• MDR Text Key: 242856467
• Report Number: 1823260-2020-02948
• 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: 03/18/2021

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 Model Number: HIV COMBI
• Device Catalogue Number: 05390095190
• Device Lot Number: 473281
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1