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 06/08/2018

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 two (2) 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 was reported as a pregnant female.Patient sample type, treatment and outcome were unknown.There is insufficient information to determine if a malfunction occurred.Attempts to gain additional information was not successful.This event is considered a malfunction due to unknown treatment and the risk of short and medium-term toxicity to the fetus being unknown.

Event Description

A customer reported nine (9) false positive results with the alere determine hiv-1/2 ag/ab combo test.No patient information was provided until 26 december 2019.This supplemental report represents two (2) of nine (9).A customer reported a false positive antigen (ag) result (sample type not otherwise specified) with the alere determine hiv-1/2 ag/ab combo test.Confirmation testing with the abbott architect was negative/nonreactive.The patient was reported as a 62 year old female (outside of reproductive age).Patient treatment and outcome are unknown.There is insufficient information to determine if a malfunction occurred.Attempts to gain additional information were not successful.Per the alere determine hiv-1/2 ag/ab combo product insert: reactive result using alere determine hiv-1/2 ag/ab combo suggests the presence of hiv-1 p24 antigen and/or antibodies to hiv-1 and/or hiv-2 in the sample.The reactive result is interpreted as preliminary positive for hiv-1 p24 antigen and/or antibodies to hiv-1 and/or hiv-2.Alere determine hiv-1/2 ag/ab combo is intended as aid in the diagnosis of infection with hiv-1/2.Reactive test results should be confirmed by additional testing using other tests.The risk will not cause or contribute to a death or serious injury.

Manufacturer Narrative

The following lots were expired at the time of the new aware date: a review of all complaint data was performed.Kit lot 098341 was expired (2019 08 23) at the time of the new aware date.A review of all complaint data was performed.(b)(4).The evidence available does not indicate that the product is performing outside label claims.Abbott diagnostics scarborough, inc.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.

• 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
• MDR Report Key: 9403286
• MDR Text Key: 220535094
• Report Number: 1221359-2019-00077
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310106477
• Combination Product (y/n): N
• PMA/PMN Number: BP120037-0
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2019
• Device Catalogue Number: 7D2648
• Device Lot Number: 098341
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR