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

Lot Number 103698

Device Problem False Positive Result (1227)

Patient Problem Pregnancy (3193)

Event Date 04/26/2019

Event Type  Injury  

Manufacturer Narrative

Testing was performed at alere (b)(4) on retained kit lots 103698 and 107842 (exp 21 july 2020) with the following internal serum/plasma control samples: (b)(6) samples.All test results were valid and performed as expected.Additionally, the manufacturing batch records for lots 103698 and 107842 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 numbers 103698 and 107842 showed that the complaint rate is (b)(4).The evidence available does not indicate that the product is performing outside label claims.Alere (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 the device lots are performing within labeled claims.

Event Description

This report represents the first of three customer reported (b)(6) results with the alere determine hiv-1/2 ag/ab combo test on serum samples from three (3) patients.(b)(6) antibody (ab) results were reported on a pregnant female patient before delivery.The test was repeated on two (2) different lots (lot #: 103698; 107842), three (3) times on each lot.Confirmatory testing on the pregnant patient was performed on a 4th generation hiv chemiluminescence test and reported as (b)(6).Rna viral load testing was performed and reported as (b)(6).Prior to confirmation of test results, a cesarean section was performed based on the (b)(6) rapid hiv test generated by the alere determine hiv-1/2 ag/ab combo.The patient received (b)(6).

• Brand Name: ALERE DETERMINE HIV-1/2 AG/AB COMBO
• Type of Device: IVD FOR HIV 1/2 AG/AB
• Manufacturer (Section D): ALERE SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: erin rowley ; 10 southgate road; scarborough, ME 04074 ; 2077305858
• MDR Report Key: 8645350
• MDR Text Key: 146227761
• Report Number: 1221359-2019-00027
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310103698
• 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: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2020
• Device Lot Number: 103698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2018
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 22 YR
• Patient Weight: 109