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 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 (b)(6) ag/ab combo batches are performing according to label claims.Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.Attempts to gain additional information were not successful.

Event Description

A customer reported false positive results on two (2) patients.The customer only provided information on patient 1.This report represents patient 2.The customer reported a false positive ag (antigen) result with the alere determine (b)(6) ag/ab combo test.Sample type, repeat testing and confirmation testing are unknown.Patient gender, pregnancy status, treatment and outcome are unknown.The customer reported that patient 2 was "reported as negative and patient information wasn't saved." 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 Contact: erin rowley ; 10 southgate road; scarborough, ME 04074 ; 2077305858
• MDR Report Key: 9454243
• MDR Text Key: 220116105
• Report Number: 1221359-2019-00085
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310106477
• 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: 12/10/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 7D2648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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