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 Problem False Positive Result (1227)

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

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

Reference mftr reports: 1221359-2020-00477, 1221359-2020-00478 testing was performed at abbott diagnostics (b)(4) inc.On retained kit lot 129586 with the following internal whole blood control samples: (b)(6) positive, (b)(6) positive, p24 positive, and (b)(6) negative.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for kit part number 7d2648 / lot 129586 and device part number 10732998 / lot 126644.This lot met the required release specifications.The current overall incident rate for false positive patient results (confirmed and unconfirmed, conflicting results) for this specific lot based on the total quantity of devices manufactured for distribution is (b)(4).Abbott diagnostics (b)(4) was unable to determine the exact root cause of the reported issue.The available evidence suggests that this device lot is performing within labeled claims.

Event Description

The customer reported three false antigen positives determine (b)(6) ag/ab combo.This report represents one of three.The customer reported false antigen positives determine (b)(6) ag/ab combo results while testing pregnant patients on (b)(6) 2020.The 50 ml edta-plasma sample was added to the test by control pipette.Confirmation testing by rna quantification (b)(6) antibody differentiation and rna quantitative pcr generated negative results.The customer confirmed there was no death or serious injury based on the test results.The customer stated the pregnant woman was tested prior to delivery.She was not treated with art while pregnant; she was not given art treatment at all.Within six hours after birth, the baby received art treatment, per texas state law for presumed positives.Per the alere determine (b)(6) ag/ab combo product insert limitations: a reactive result using alere determine (b)(6) ag/ab combo suggests the presence of (b)(6) p24 antigen and/or antibodies to (b)(6) and/or (b)(6) in the sample.The reactive result is interpreted as preliminary positive for (b)(6) p24 antigen and/or antibodies to (b)(6) and/or (b)(6).Alere determine (b)(6) ag/ab combo is intended as aid in the diagnosis of infection with (b)(6).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 false positive test results.This shall be considered reportable as a malfunction, as the risk of short and medium-term toxicity to the infant with the current art prophylaxis regimens is unknown.

• 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
• Manufacturer (Section G): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: alonna pitreau ; 10 southgate road; scarborough, ME 04074 ; 2077305717
• MDR Report Key: 11066602
• MDR Text Key: 240633664
• Report Number: 1221359-2020-00466
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310129586
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BP120037-0
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/10/2021
• Device Catalogue Number: 7D2648
• Device Lot Number: 129586
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1