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	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.A supplemental report will be provided after completion.
Event or Problem Description
The customer reported (b)(6) results with the alere determine hiv ¿ ag/ab combo test performed on (b)(6) 2021.The customer reported testing a whole edta blood sample and retesting and retesting was performed 2x with the same box and 1x on an unopened box.Three total stripes were strips were tested.The serum and plasma samples were added to the tests by mla pippette.Both tests generated antibody (ab) (b)(6) results.Confirmation testing was performed and sent to (b)(6) (diagnostic methodology not provided) generated (b)(6) results.The patient was not known to be (b)(6) at the time of testing.The (b)(6) year old female in labor and delivery.The test was performed prior to delivery.The patient did not receive art based on the alere determine hiv-1/2 ag/ab combo results.The patient experienced a 'normal' vaginal delivery.The customer reported that (b)(6) drugs were administered to the baby.There was no death or serious injury to the patient based on the results.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the investigation conclusion.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 153829 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 153829 and test base part number 10732998 / lot 152121.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 153829 showed that the complaint rate is (b)(4).In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue, however it could be attributed to the specific patient sample.The sample may have contained specific substances which may have affected the results.

• 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
• Manufacturer Contact: erina marshall ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 12194440
• Report Number: 1221359-2021-02056
• Device Sequence Number: 4172771
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310153829
• 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,Followup
• Report Date (Section B): 04/01/2022

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 Expiration Date: 07/12/2022
• Device Catalogue Number: 7D2648
• Device Lot Number: 153829
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 60 KG