MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH INC. DETERMINE HIV - 1/2 AG/AB COMBO; IVD FOR HIV 1/2 AG/AB

Catalog Number 7D2648

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in process.A supplemental report will be submitted after completion.Please see related mfr report # 1221359-2020-00401.

Event Description

A customer reported 2 (b)(6) results with the determine hiv 1/2 ag/ab combo 25t.This report represents patient two (2) of two (2).The customer reported the results as p-24 antigen (ag) positive.Sample information was not provided.Confirmatory testing results (not specified) were (b)(6).No further patient information was provided.There was no death based on the determine hiv 1/2 ag/ab combo results.The alere hiv 1/2 ag-ab product insert indicates reactive test results should be confirmed by additional testing using other tests.Specimens from individuals with toxoplasma igg, human anti-mouse antibodies, rheumatoid factor, elevated triglycerides (above 600 mg/dl), herpes simplex virus infection, hospitalized, and cancer patients may give (b)(6) test results.When the source patient is ag and/or ab (b)(6), and receives unnecessary short-term art treatment, the risk of short- and medium-term toxicity with the current recommended art prophylaxis regimen is primarily transient metabolic abnormalities, which appear to be primarily mild and reversible after treatment is interrupted.As the sex and/or pregnancy status of the patient is unknown, given that the risk of short and medium-term toxicity to a possible fetus is unknown, this case shall be reported.

Manufacturer Narrative

Additional information was received on 24nov2020 that identified the patient as a female confirmed to not be pregnant (confirmed (b)(6) 2020).Based on this information this event is no longer reportable.Risk of short- and medium-term toxicity to patient with the current recommended art prophylaxis regimens is primarily transient metabolic abnormalities which appears to be primarily mild and reversible after treatment is interrupted.The risk will not cause or contribute to a death or serious injury and is therefore considered not reportable.Additional information: a3.

• Brand Name: DETERMINE HIV - 1/2 AG/AB COMBO
• Type of Device: IVD FOR HIV 1/2 AG/AB
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH INC.; 10 southgate road; scarborough ME 04074
• MDR Report Key: 10904435
• MDR Text Key: 221017839
• Report Number: 1221359-2020-00404
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• PMA/PMN Number: BP120037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7D2648
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1