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

Catalog Number 7D2648

Device Problem False Negative Result (1225)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

No kit lot number was provided for a specific investigation.No sample was returned for further testing, and no additional information was provided.A review of complaint trends revealed that all of the alere determine hiv ½ ag/ab lots are performing according to label claims.The exact root cause of the reported issue could not be determined.The available evidence suggests that the device is performing within labeled claims.

Event Description

A customer reported a (b)(6) result with the alere determine hiv 1/2 ag/ab combo.There is insufficient information to determine if a malfunction occurred.The patient gender, pregnancy status, treatment and patient outcome were unknown.The exact date of occurrence was not provided.No device lot number was reported.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): ALERE SCARBOROUGH INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: benjamin crystal ; 10 southgate road; scarborough, ME 04074 ; 2077305820
• MDR Report Key: 8088769
• MDR Text Key: 127869533
• Report Number: 1221359-2018-00544
• 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: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• 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: 10/26/2018
• 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