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 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

Testing was performed at abbott diagnostics (b)(6).On retained kit lots: 106477, 107755, 108399, 109469, 110100, 109895, 108250, and 108941 with the following internal whole blood and serum/plasma: (b)(6).All test results were valid and performed as expected.Additionally, the manufacturing batch records for lots 106477, 107755, 108399, 109469, 110100, 109895, 108250, and 108941 were reviewed.These lots met the required release specifications.A review of the complaints reported as false positive related to the below lot numbers showed that the complaint rate is: kit lot:106477 - (b)(4).Kit lot 107755 - (b)(4).Kit lot 108399 - (b)(4).Kit lot 109469 - (b)(4).Kit lot 110100 - (b)(4).Kit lot 109895 - (b)(4).Kit lot 108250 - (b)(4).Kit lot 108941 - (b)(4).The evidence available does not indicate that the product is performing outside label claims.Abbott diagnostics (b)(6) 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

A customer reported nine (9) (b)(6) results with the alere determine (b)(6) test.This report represents nine (9) of the nine (9) (b)(6) (ag/ab not specified) alere determine (b)(6) patient results reported from a customer.Confirmation testing (methodology not otherwise specified) was (b)(6).The patient gender, pregnancy status, treatment and outcome were 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: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 9403288
• MDR Text Key: 220536316
• Report Number: 1221359-2019-00084
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310106477
• 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,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Catalogue Number: 7D2648
• Device Lot Number: 106477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 12/03/2019
• Supplement Dates Manufacturer Received: 12/30/2019
• Supplement Dates FDA Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2019
• 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: 29 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic