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

Catalog Number 08P07-22

Device Problem Low Test Results (2458)

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

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no further patient information provided due to privacy issues.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 reported (b)(6) alinity i hiv result on one patient compared to the roche cobas method.The results provide were: (b)(6) 2020 (b)(6) alinity = (b)(6) / repeat = (b)(6)/ repeat test = (b)(6).There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for lot 11210be00, and no trends were identified for the complaint issue.Returns were not required for testing during the investigation.Sensitivity testing was performed with a retained kit of lot 11210be00 and a sensitivity setup.Results of this testing did not implicate that the sensitivity performance of the lot is negatively impacted.The reagent kit showed normal performance without false non-reactive results.In addition, the clinical sensitivity of the lot was evaluated by testing two commercially available seroconversion panels (zeptometrix hiv 9016 and hiv 9018).The seroconversion panel results were compared to architect hiv ag/ab combo test results provided by zeptometrix.The lot detected the same bleeds as reactive for the seroconversion panels.Based on this data it was shown that the sensitivity performance of the lot is not affected.Note: alinity i ag/ab combo is equivalent to architect hiv ag/ab combo (same bulk reagents).A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product 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 11210be00.

• Brand Name: ALINITY I HIV AG/AB COMBO
• Type of Device: HIV-1 AND HIV-2 ANTIGENS AND ANTIBODIES
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9706173
• MDR Text Key: 200659404
• Report Number: 3002809144-2020-00111
• 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
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2020
• Device Catalogue Number: 08P07-22
• Device Lot Number: 11210BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2020
• 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,; SERIAL # (B)(4); SERIAL # (B)(4)