MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T; 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 07/21/2022

Event Type  malfunction  

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Mfr reference: 1221359-2022-04248 through 1221359-2022-04250.

Event Description

The customer reported three (3) false positive results with the determine hiv 1/2 ag/ab combo 25t for three patients performed on multiple dates.This mfr.Report addresses patient 2 of 3.The consumer reported a false positive result with the determine hiv 1/2 ag/ab combo 25t test on (b)(6) 2022.Confirmatory testing was performed and generated a negative result, also customer confirmed patient was pregnant and test was performed before delivery.As per customer no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.

Manufacturer Narrative

H10: testing was performed at abbott diagnostics scarborough, inc.On retained kit lot lot 177935 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 177935, test base part number 10732998 / lot 169496.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 177935 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.However a possible assignable root cause is sample interference or cross contamination.Mfr reference: 1221359-2022-04248 through 1221359-2022-04250.

• Brand Name: ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T
• 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: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 15149940
• MDR Text Key: 305070724
• Report Number: 1221359-2022-04249
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310177935
• 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,Followup
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/02/2023
• Device Catalogue Number: 7D2648
• Device Lot Number: 177935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 22 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White