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 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 262540416
• Report Number: 1221359-2021-02056
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310153829
• 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
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• 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
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2021
• 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
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 60 KG