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 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

Testing was performed at abbott diagnostics (b)(6) on retained kit lot 110834, 111287 and 103972 with the following internal serum/plasma and whole blood qc panel samples: (b)(6).All test results were valid and performed as expected.Additionally, the manufacturing batch records for lots 110834, 111287 and 103972 were reviewed.This lot met the required release specifications.A review of the complaints reported as (b)(6) related to lot numbers 110834, 111287 and 103972 showed that the complaint rate is (b)(4), respectively.The evidence available does not indicate that the product is performing outside label claims.Abbott diagnostics (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

A customer reported (b)(6) and conflicting results between two (2) sample types from the same patient with the alere determine (b)(6) combo.The customer reported dual (b)(6) results on a plasma sample with the alere determine (b)(6) combo.The sample was repeated on two (2) additional lots (3 lots total), all generating dual ag/ab (b)(6) results.The customer reported (b)(6) results on a slightly hemolyzed serum sample from the same patient with the alere determine (b)(6) combo.The sample was repeated on two (2) additional lots (3 lots total), all generating ab (b)(6) results.Confirmation testing on the abbott architect and biorad genius was (b)(6).The patient was reported as a pregnant female.The patient did not receive art based on the alere determine (b)(6) combo test results.Additionally, no surgical procedures, including cesarean section, were performed based on the results.Conflicting results indicate a malfunction of one of the tests as it is expected that testing the same patient sample or a second sample from the same patient tested on the same day as the original sample would return the same result.

• 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: 9371664
• MDR Text Key: 220532850
• Report Number: 1221359-2019-00074
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 0110811877010293101110834
• 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: 11/28/2020
• Device Catalogue Number: 7D2648
• Device Lot Number: 110834
• 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: 29 YR