MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS 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 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

Testing was performed at alere (b)(4) on retained kit lot 108146 with the following internal whole blood control samples: (b)(6).All test results were valid and performed as expected.Additionally, the manufacturing batch records for lot 108146 were reviewed.This lot met the required release specifications.A review of the complaints reported as false positive or unconfirmed false positive related to lot number 108146 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 this device lot is performing within labeled claims.

Event Description

This report represents the 3rd of 3 (b)(6) patient results which occurred with the alere determine hiv 1/2 ag/ab combo on blood samples.A confirmatory test (not otherwise specified) which was performed at (b)(6) was (b)(6) for (b)(6).There is insufficient information to determine if a malfunction occurred.The patient was reported as female but pregnancy and treatment status were not provided.

• Brand Name: ALERE DETERMINE HIV 1/2 AG/AB COMBO
• Type of Device: IVD FOR HIV AG/AB
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: benjamin crystal ; 10 southgate road; scarborough, ME 04074 ; 2077305820
• MDR Report Key: 8786084
• MDR Text Key: 193670903
• Report Number: 1221359-2019-00039
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310108146
• 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: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2020
• Device Catalogue Number: 7D2648
• Device Lot Number: 108146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2019
• 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
• Patient Age: 49 YR