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.The results obtained may possibly be related to the patient sample.The samples may have contained specific substances which may have affected the results.Please refer to the kit's package insert under the section limitations of the test: "reactive test results should be confirmed by additional testing using other tests." "specimens from individuals with toxoplasma igg, human anti-mouse antibodies, rheumatoid factor, elevated triglycerides, herpes simplex virus infection, and hospitalized and cancer patients may give false positive test results.".

Event Description

This report represents the first of two (b)(6) ab results reported on patient serum samples tested with the alere determine hiv 1/2 ag/ab combo.Confirmatory testing on the geenius hiv and abbott architect tests were (b)(6).There is insufficient information to determine if a malfunction occurred.The patient gender, pregnancy status, treatment and patient outcomes are unknown.The exact date of occurrence was not 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: 9147831
• MDR Text Key: 219995611
• Report Number: 1221359-2019-00064
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• 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: 09/09/2019
• 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