MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. DETERMINE HIV 1/2 AG/AB COMBO 25T; 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	06/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a (b)(6) antibody (ab) result on an edta whole blood sample with the alere determine hiv 1/2 ag/ab combo.Repeat testing on the same kit lot generated (b)(6) results.Confirmation testing was (b)(6) testing (not otherwise specified).The patient was reported as a pregnant female.The patient received art based on the alere determine hiv-1/2 ag/ab combo test.The customer confirmed that no surgical procedures were performed due to the (b)(6) result.Patient outcome is unknown.
Additional Manufacturer Narrative
Testing was performed at abbott diagnostics (b)(4) inc.On retained kit lot 119305 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 7d2648 / lot 119305 and device part number 10732998 / lot 118361 the lot met the required release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 119305 showed that the complaint rate is (b)(4).Abbott diagnostics (b)(4) was unable to determine the exact root cause of the reported issue, however it could be attributed to the specific patient samples.

• Brand Name: DETERMINE HIV 1/2 AG/AB COMBO 25T
• 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: 12683135
• Report Number: 1221359-2021-03235
• Device Sequence Number: 19891921
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310119305
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Type of Report: Initial
• Report Date (Section B): 10/22/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2021
• Device Catalogue Number: 7D2648
• Device Lot Number: 119305
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 60