MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 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 Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 09/24/2019

Event Type  malfunction  

Manufacturer Narrative

Testing was performed at abbott diagnostics (b)(4).On retained kit lot 111287 with the following internal serum/plasma and whole blood samples: (b)(6).All test results were valid and performed as expected.Additionally, the manufacturing batch records for lot 111287 were reviewed.This lot met the required release specifications.A review of the complaints reported as (b)(6) related to lot number 111287 showed that the complaint rate is (b)(4).The evidence available does not indicate that the product is performing outside label claims.Abbott diagnostics (b)(4) 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 this device lot is performing within labeled claims.

Event Description

Customer reported a (b)(6) antigen (ag) result on a edta plasma sample with the alere determine hiv-1/2 ag/ab combo test.Repeat testing was performed on the same kit lot # yielding (b)(6) ag results.Confirmation testing on the abbott architect and biorad evolis was (b)(6).The patient was reported as female.Pregnancy status, treatment (art) and outcome are unknown.There is insufficient information to determine if a malfunction occurred.Attempts to gain additional 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: 9215355
• MDR Text Key: 220000721
• Report Number: 1221359-2019-00070
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310111287
• 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2021
• Device Catalogue Number: 7D2648
• Device Lot Number: 111287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2019
• 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