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

Device Problem False Negative Result (1225)

Patient Problems HIV, Human Immunodeficiency Virus (2197); No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 07/04/2019

Event Type  malfunction  

Manufacturer Narrative

Testing was performed at abbott diagnostics (b)(4), inc.On retained kit lots: 102997, and 108538 with the following serum/plasma control samples: (b)(6).All test results were valid and performed as expected.The customer returned the patient sample collected on (b)(6) 2019.The sample was tested with x1 device from each kit lot.Both tests yielded valid, reactive p24 antigen results.Please note: the customer stated they stored the samples at a refrigerated temperature since collection.The sample arrived at abbott diagnostics (b)(4) on tested on (b)(6) 2019.According to the package insert under the section specimen storage: serum and plasma specimens may be stored at room temperature (15- 30°c) for up to two days before testing.If testing will not be performed within two days of sample collection, serum and plasma specimens should be stored at 2- 8°c if the test is to be run within 7 days of collection.If testing is delayed more than 7 days, the specimen should be frozen (-20°c or colder).The manufacturing batch records for lots: 102997 and 108538 were reviewed.This lot met the required release specifications.A review of the complaints reported as (b)(6) related to lot numbers 102997 and 108538 showed that the complaint rate is (b)(4)., respectively.The evidence available does not indicate that the product is performing outside label claims.Abbott diagnostics (b)(4), inc.Was unable to determine the exact root cause of the reported issue.

Event Description

A customer reported a (b)(6) result on a serum sample (collection date: (b)(6) 2019) with the alere determine hiv-1/2 ag/ab combo test (kit lot # 102997) on a male patient.Confirmatory testing from a serum sample (collection date: (b)(6) 2019) produced (b)(6) results with the abbott architect; (b)(6) results with the biorad geenius; (b)(6) results with an hiv-1 rna qualitative assay (not otherwise specified).Repeat testing on (b)(6) 2019 of the serum samples, collection dates: (b)(6) 2019 and (b)(6) 2019 were negative with the alere determine hiv-1/2 ag/ab combo test (kit lot # 102997).Additional testing (serum sample, collection date: (b)(6) 2019) was negative with the alere determine hiv-1/2 ag/ab combo test on (b)(6) 2019 with kit lot # 108538.Testing of the serum sample, collection date: (b)(6) 2019, produced (b)(6) results with the abbott architect and (b)(6) results with the biorad geenius when tested.Note: package insert specimen storage states: serum and plasma specimens may be stored at room temperature (15- 30°c) for up to two days before testing.If testing will not be performed within two days of sample collection, serum and plasma specimens should be stored at 2- 8°c if the test is to be run within 7 days of collection.If testing is delayed more than 7 days, the specimen should be frozen (-20°c or colder).Mix specimen well by gentle inversion of the tube immediately before testing.Treatment and patient outcome were not reported.There is insufficient information to determine if a malfunction occurred.Attempts to gain additional information were not successful.

• Brand Name: ALERE 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 (Section G): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: erin rowley ; 10 southgate road; scarborough, ME 04074 ; 2077305858
• MDR Report Key: 8887707
• MDR Text Key: 219159755
• Report Number: 1221359-2019-00057
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310102997
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2020
• Device Catalogue Number: 7D2648
• Device Lot Number: 102997
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/02/2018
• 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: 33 YR