MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I HIV AG/AB COMBO; HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES

Catalog Number 08P07-32

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

Patient (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 8p07-22 that has a similar product distributed in the us, list number 8p07-21.

Event Description

The customer observed (b)(6) hiv ag/ab on alinity i processing module for one patient.The results provided were: (b)(6) initial result= (b)(^), repeated =(b)(6) on strip hiv (1+2) antibody= (b)(6), retest on siemens advia= 3.81 index (<1.0 index) there was no reported impact to patient management.

Event Description

The customer observed false nonreactive hiv ag/ab on alinity i processing module for one patient.The results provided were: (b)(6) 2020 sid (b)(6) initial result= 0.28 s/co (<1.00= nonreactive), repeated =0.27 s/co(previous history was hiv reactive), repeated on strip hiv (1+2) antibody= reactive, retest on siemens advia= 3.81 index (<1.0 index).Patient history : patient history was hiv reactive and treated with anti-viral drug name teevir/gpo-virt.Patient sample was send to confirm hiv reactive with hiv second generation = reactive.There was no reported impact to patient management.

Manufacturer Narrative

B5.Additional patient history and testing provided: patient history: patient history was hiv reactive and treated with anti-viral drug name teevir/gpo-virt.Patient sample was send to confirm hiv reactive with hiv second generation = reactive.D4.Updated list# to 08p07-32 from 08p07-22.

Manufacturer Narrative

The evaluation of complaint data for the product and likely cause alinity i hiv ag/ab combo reagent lot 07200be00 determined that there is normal complaint activity.There are no trends for the product related to patient results.A retained kit of reagent lot 07200be00 was tested for specificity and the data shows that the specificity performance of lot 07200be00 is not adversely affected.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity i hiv ag/ab combo reagent lot 07200be00.

• Brand Name: ALINITY I HIV AG/AB COMBO
• Type of Device: HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9732918
• MDR Text Key: 224288448
• Report Number: 3002809144-2020-00134
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2020
• Device Catalogue Number: 08P07-32
• Device Lot Number: 07200BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESSING MODULE LN 03R65-01.; ALINITY I PROCESSING MODULE LN 03R65-01.; ALINITY I PROCESSING MODULE.; LN 03R65-01, SERIAL (B)(4). ; SERIAL (B)(4). ; SERIAL (B)(4).