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 Positive Result (1227)

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

Event Date 11/20/2018

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 (b)(6) lots are performing according to label claims.The exact root cause of the reported issue could not be determined.The results obtained may possibly be related to the patient sample.The sample may have contained specific substances which may have affected the results.The available evidence suggests that the device is performing within labeled claims.

Event Description

A customer reported two (b)(6) results with the alere determine (b)(6) combo.There is insufficient information to determine if a malfunction occurred.The exact number of patient or patients was not reported.The patient(s) gender, pregnancy status, treatment and patient outcome were unknown.No device lot number was provided.Attempts to gain additional patient information were not successful.

Manufacturer Narrative

Risk of short- and medium-term toxicity to (male) patient with the current recommended art prophylaxis regimens is primarily transient metabolic abnormalities which appears to be primarily mild and reversible after treatment is interrupted.The risk will not cause or contribute to a death or serious injury and is therefore considered not reportable.

Event Description

(b)(6) 2018: additional information: both patients were reported as male.There was one ag and one ab positive alere determine hiv 1/2 ag/ab combo test result.The confirmatory negative testing was performed with an hiv 4th generation test.

• 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
• MDR Report Key: 8077328
• MDR Text Key: 129310231
• Report Number: 1221359-2018-00543
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• PMA/PMN Number: BP120037-0
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• 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
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1