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

Lot Number 094279

Device Problem False Positive Result (1227)

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

Event Type  malfunction  

Manufacturer Narrative

Testing was unable to be performed at abbott diagnostics (b)(4) on the kit retain.Kit lot 094279 expired at the time of reporting the complaint.The kit lot was found to be performing within label claims when tested during its shelf life.The manufacturing batch records for kit lot 094279 were reviewed.This lot met the required release specifications.A review of the complaints reported as (b)(6) or unconfirmed (b)(6) related to lot number 094279 showed that the complaint rate is 0.034%.The evidence available does not indicate that the product is performing outside label claims.Abbott scarborough was unable to determine the exact root cause of the reported issue.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 lots are performing within labeled claims.

Event Description

Abbott virology solutions specialist (vss) reported that a customer has received "2 or maybe 3" (b)(6) results on the alere determine hiv-1/2 ag/ab combo.Two (2) tests were reported as confirmed (b)(6) antibody (ab) results.There is insufficient information to determine if a malfunction occurred.The exact number of patients involved, their gender, pregnancy status, treatment, and patient outcomes were unknown.No exact date or dates of occurences were 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 1/2 AG/AB
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: erin rowley ; 10 southgate road; scarborough, ME 04074 ; 2077305858
• MDR Report Key: 8734392
• MDR Text Key: 213449482
• Report Number: 1221359-2019-00035
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310094279
• 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: 06/24/2019

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 Expiration Date: 04/09/2019
• Device Lot Number: 094279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2017
• 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