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

Catalog Number 08924163190

Device Problem False Negative Result (1225)

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

Event Date 09/11/2023

Event Type  malfunction  

Event Description

The initial reporter questioned negative results for 1 patient tested for elecsys hiv combi pt (hiv combi) on a cobas e 411 analyzer (rack system).On (b)(6) 2023.The patient allegedly visited the thailand red cross to provide a blood donation.The patient was reportedly tested by the thailand red cross with the following results: the chemiluminescent microparticle immuno assay (cmia) abbott method result was reportedly 4.12 s/co (positive).The alere determine result was reportedly weekly positive (w).The hiv rna result was reportedly positive.On (b)(6) 2023.The initial result from the e411 analyzer was reportedly 0.80 coi (negative).The repeat result was reportedly 0.7 coi (negative).The negative results were allegedly reported outside of the laboratory.The patient reportedly informed the physician of the positive results from the thailand red cross and the physician requested additional testing.The customer repeated the ethylenediamine tetraacetic acid (edta) plasma sample from 11-sep-2023 in a cup on the e411 analyzer and the result was reportedly 0.731 coi (negative).The customer repeated the serum and edta plasma samples from (b)(6) 2023 by different methods and obtained the following results: the abbott determine result was reportedly positive for both the serum and the edta plasma sample.The wondfo method result was reportedly positive for both the serum and the edta plasma sample.The customer sent the serum sample to an external laboratory for testing and the hiv duo result from a cobas e801 module was reportedly 0.341 coi (negative).On (b)(6) 2023 a new sample was obtained.The result from the e411 analyzer was reportedly 190.1 coi (positive.

Manufacturer Narrative

Qc was acceptable.On (b)(6) 2023 service personnel visited the customer to check the instrument and the reagent.A new calibration was performed and qc was repeated with passing results.The patient sample in question and a control sample were reportedly tested for troubleshooting purposes with the following results: the patient sample in question was run on the e411 analyzer and the result was reportedly 0.785 coi (negative).The control sample was run on the e411 analyzer and the result was reportedly 369.4 coi (positive).The patient sample was sent to another laboratory using an e411 analyzer and the result was reportedly 0.789 coi (negative).The control sample was sent to another laboratory using an e411 analyzer and the result was reportedly 345.7 coi (positive).The patient sample was sent to a different hospital using a cobas e801 module and the hiv duo result was reportedly 0.536 coi (negative).The control sample was sent to a different hospital using a cobas e801 module and the hiv duo result was reportedly 289 (positive).The patient sample in question was requested for investigation.

Manufacturer Narrative

Calibration data was acceptable.Liquid flow cleaning was last performed on (b)(6) 2023.A serum and plasma sample (same draw) from the patient was submitted for investigation.Elecsys hiv combi results: serum sample: 0.694 coi (negative).Plasma sample: 0.783 coi (negative).These results are considered to be elevated negative results.Further investigation showed both samples were positive with one hiv-1 specific antigen of the elecsys hiv combi assay.The serum sample was tested with biorad new lav blot i, the biorad new lav blot ii, and the fujirebio inno-lia hiv i/ii score.The sample showed one faint band (p24) in the biorad hiv-1 blot (indeterminate) and showed no band in the biorad hiv-2 blot (negative).These results lead to an indeterminate hiv-1 blot result.In the inno-lia hiv i/ii score the sample showed no band which leads to a negative result interpretation.Based on the investigation results, the patient sample was likely drawn during the very early seroconversion phase.In this early phase of infection, the hiv analyte concentration could be very low which may lead to negative results.A negative test result does not completely rule out the possibility of an infection with hiv.Serum or plasma from the very early phase of hiv infections can occasionally yield negative findings.For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings.The elecsys hiv combi pt performs within specification.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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17912371
• MDR Text Key: 325392463
• Report Number: 1823260-2023-03255
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): Y
• Reporter Country Code: TH
• PMA/PMN Number: BP160050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

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: 03/31/2024
• Device Catalogue Number: 08924163190
• Device Lot Number: 704432
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male