MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH 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 Information (3190); Missing Value Reason (3192)

Event Type  malfunction  

Manufacturer Narrative

The required information to enable further investigation, such as the kit lot numbers, was not provided and an investigation was not able to be performed.Notwithstanding, a review of complaints' trend reveals that all lots within expiry dating at that time were 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 a high ratio of false positive results with the alere determine (b)(6) over a three month period.It was indicated that there were 4 false positives in (b)(6) 2019.The customer did not report if the false positive results were (b)(6).The exact dates of occurrence were not provided and no mode of confirmation testing was indicated.No specific lot numbers were provided.There is insufficient information to determine if a malfunction occurred.No information regarding patient gender, pregnancy status, treatment or outcomes were provided.

• 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; 10 southgate rd; scarborough ME 04074
• Manufacturer Contact: benjamin crystal ; 10 southgate rd; scarborough, ME 04074 ; 2077305820
• MDR Report Key: 8959581
• MDR Text Key: 219780244
• Report Number: 1221359-2019-00061
• 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: 09/04/2019

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: 08/13/2019
• Initial Date FDA Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: No
• 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