MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH INC. ALERE DETERMINE HIV 1/2 AG/AB COMBO; IVD FOR HIV 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, 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

This report represents the second of two (2) (b)(6) results reported with the alere determine hiv 1/2 ag/ab combo.The sample type was not provided.Confirmatory testing (not otherwise specified) was (b)(6).There is insufficient information to determine if a malfunction occurred.The patient gender, pregnancy status, treatment and patient outcome were unknown.No device lot number or date of occurrence was provided.Attempts to gain additional patient information were not successful.

• Brand Name: ALERE DETERMINE HIV 1/2 AG/AB COMBO
• Type of Device: IVD FOR HIV AG/AB
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: benjamin crystal ; 10 southgate road; scarborough, ME 04074 ; 2077305820
• MDR Report Key: 8701469
• MDR Text Key: 191858775
• Report Number: 1221359-2019-00034
• 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: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 05/21/2019
• Initial Date FDA Received: 06/14/2019
• 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