MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ALERE 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 Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Testing was performed at abbott diagnostics (b)(6) on retained kit lot 114861 with the following internal serum/plasma control samples:(b)(6).All test results were valid and performed as expected.Additionally, the manufacturing batch records for lot 114861 were reviewed.This lot met the required release specifications.A review of the complaints reported as (b)(6) (confirmed and unconfirmed) related to lot number 114861 showed that the complaint rate is (b)(6).The evidence available does not indicate that the product is performing outside label claims.Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.The results obtained may possibly be related to the patient sample.The sample may have contained specific substances which may have affected the results.The available evidence suggests that this device lot is performing within labeled claims.
Event or Problem Description
A customer reported a (b)(6) (ag/ab not otherwise specified) result on a serum sample with the alere determine hiv-1/2 ag/ab combo test.Confirmation testing (methodology not otherwise specified) was (b)(6).The patient was reported as a pregnant female (first trimester).The customer stated they "didn't believe" art was administered based on the alere determine hiv-1/2 ag/ab results.The customer reported there was no death, serious injury or surgical procedures performed based on the results.There is insufficient information to determine if a malfunction occurred.Patient treatment and patient outcome are unknown.Attempts to gain additional patient information were not successful.

• Brand Name: ALERE 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
• MDR Report Key: 9746731
• Report Number: 1221359-2020-00009
• Device Sequence Number: 13946745
• Product Code: MZF
• UDI-Device Identifier: 10811877010323
• UDI-Public: 011081187701032310114861
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: BP120037-0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2020

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: Health Professional
• Device Expiration Date: 03/17/2021
• Device Catalogue Number: 7D2648
• Device Lot Number: 114861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR