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 Positive Result (1227)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 02/08/2020

Event Type  malfunction  

Manufacturer Narrative

Testing was performed at abbott diagnostics (b)(6), inc.On retained kit lot 115434 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 115434 were reviewed.This lot met the required release specifications.A review of the complaints reported as false positive or unconfirmed false positive related to lot number 115434 showed that the complaint rate is (b)(4).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.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 Description

A customer reported four (4) (b)(6) results with alere determine hiv-1/2 ag/ab combo.This report represents three (3) of four (4).The customer reported a (b)(6) antibody (ab) result on a serum sample with alere determine hiv-1/2 ag/ab combo.Confirmation testing (methodology: molecular viral load) was reported as (b)(6).The patient gender, pregnancy status, treatment and outcome were unknown.The customer stated there was no death or serious injury based on the alere determine hiv-1/2 ag/ab combo result.There is insufficient information to determine if a malfunction occurred.Attempts to gain additional patient information were no 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
• Manufacturer Contact: erin rowley ; 10 southgate road; scarborough, me ; 7305858
• MDR Report Key: 9851049
• MDR Text Key: 221030788
• Report Number: 1221359-2020-00014
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310115434
• 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
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2021
• Device Catalogue Number: 7D2648
• Device Lot Number: 115434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2020
• 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