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 01/27/2020

Event Type  malfunction  

Manufacturer Narrative

Testing was performed at abbott diagnostics (b)(4).On retained kit lot 115049 with the following internal whole blood control samples: (b)(6) positive, (b)(6) positive, p24 positive, and (b)(6) negative.All test results were valid and performed as expected.Additionally, the manufacturing batch records for lot 115049 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 115049 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).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 a false positive antibody (ab) result on a whole blood sample with the alere determine (b)(6) ag/ab combo.Confirmation testing (methodology not otherwise specified) was non-reactive.The patient gender, pregnancy status, treatment and patient outcome were unknown.Attempts to gain additional patient information were not successful.There is insufficient information to determine if a malfunction occurred.

Event Description

A customer reported a false positive antibody (ab) result on a fingerstick whole blood capillary sample with the alere determine hiv-1/2 ag/ab combo.Confirmation testing (methodology not otherwise specified) on a venous whole blood sample was non-reactive for hiv-1/2.The patient was reported as a non-pregnant female.The patient did not receive art based on the alere determine hiv-1/2 ag/ab combo results.Patient outcome is unknown.The customer reported there was no death or serious injury based on the alere determine hiv-1/2 ag/ab combo.Patient outcome is unknown.

Manufacturer Narrative

Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 115049 with the following internal whole blood control samples: hiv-1 positive, hiv-2 positive, p24 positive, and hiv negative.All test results were valid and performed as expected.Additionally, the manufacturing batch records for lot 115049 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 115049 showed that the (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
• MDR Report Key: 9818603
• MDR Text Key: 227200066
• Report Number: 1221359-2020-00011
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310115049
• 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: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2021
• Device Catalogue Number: 7D2648
• Device Lot Number: 115049
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 84