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 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

The required information to enable further investigation, such as the kit's lot number and patient's medical history, was not available and therefore a root cause investigation was not performed.A review of complaints' trend reveal that all of the alere determine hiv 1/2 ag/ab combo batches are performing according to label claims.The exact root cause of the reported issue could not be determined.Attempts to gain additional information were not successful.

Event Description

A customer reported (b)(6) antibody (ab) result with the alere determine hiv-1/2 ag/ab combo test.Confirmation testing (methodology not otherwise specified) was (b)(6) for (b)(6) antibody.The patient gender, pregnancy status, treatment and outcome were unknown.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
• Manufacturer Contact: erin rowley ; 10 southgate road; scarborough, me ; 7305858
• MDR Report Key: 10126768
• MDR Text Key: 230487896
• Report Number: 1221359-2020-00086
• Device Sequence Number: 1
• Product Code: MZF
• 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: 06/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7D2648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2019
• 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