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
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference mftr reports: 1221359-2020-00466, 1221359-2020-00477.Testing was performed at alere (b)(4) on retained kit lot 129586 with the following internal whole blood control samples: (b)(6).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 (b)(4) patient results (confirmed and unconfirmed, conflicting results) for this specific lot based on the total quantity of devices manufactured for distribution is (b)(6).Abbott diagnostics scarborough 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 or Problem Description
The customer reported 3 (b)(6) antigen positives determine (b)(6) combo.This report represents 3 of 3.The customer reported (b)(6) determine (b)(6) 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 (b)(6) 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 6 hours after birth, the baby received art treatment, per (b)(6) state law for presumed positives.Per the alere determine (b)(6) combo product insert limitations: a reactive result using alere determine (b)(6) combo suggests the presence of (b)(6) antigen and/or antibodies to (b)(6) in the sample.The reactive result is interpreted as preliminary (b)(6) for (b)(6) antigen and/or antibodies to (b)(6).Alere determine (b)(6) 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), (b)(6) virus infection, hospitalized and cancer patients may give (b)(6) 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
• Common Device Name: IVD FOR HIV 1/2 AG/AB
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• MDR Report Key: 11066626
• Report Number: 1221359-2020-00478
• Device Sequence Number: 16460053
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310129586
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BP120037-0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2020

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
• Operator of Device: No Information
• Device Expiration Date: 12/10/2021
• Device Catalogue Number: 7D2648
• Device Lot Number: 129586
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1