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 Problems False Positive Result (1227); Non Reproducible Results (4029)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

Testing was performed at abbott diagnostics (b)(4), inc.On retained kit lot 108146 with the following internal whole blood qc panel 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 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), 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.

Event Description

A customer reported observing two (2) different results on a capillary fingerstick sample within the acceptable read time with the alere determine hiv-1/2 ag/ab combo test.The customer reported that the alere determine hiv-1/2 ag/ab combo test was (b)(6) for ag/ab when the result was read at 20 minutes.At 22 minutes, the customer reported observing an "extremely faint line" in the antibody (ab) window of the test strip.Repeat testing was performed on the same kit lot, yielding (b)(6) results.Confirmation testing was not performed.The alere determine hiv-1/2 ag/ab combo product insert states: read the test result between 20 and 30 minutes after the addition of chase buffer.Do not read test results after 30 minutes.In this case, the initial result (20 mins) was read as nonreactive, followed by a positive ab read (22 mins).The customer stated that they "would not consider the test a (b)(6)" because they could not interpret the test; they considered it "indeterminate." the patient was reported as male.The patient did not receive art based on the alere determine hiv-1/2 ag/ab combo test results.The outcome of the patient is unknown.Conflicting results indicate a malfunction of the test as it is expected that the device will give stable results until 30 minutes.

• 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: 9371663
• MDR Text Key: 205169880
• Report Number: 1221359-2019-00075
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 0110811877010293101108416
• 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: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2020
• Device Catalogue Number: 7D2648
• Device Lot Number: 108416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2019
• 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: 33 YR