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

Catalog Number 08P07-77

Device Problem Low Test Results (2458)

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

Event Date 12/21/2019

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 by the customer.

Event Description

The customer reported (b)(6) alinity i hiv results on one patient.The results provided were: on (b)(6) 2019 sid (b)(6) initial = (b)(6).New sample on (b)(6) 2019 sid (b)(6) alinity = (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 04508be01 (including sublots and associated lots) and no trends were identified for the complaint issue.Return testing was not completed as returns were not available.Sensitivity testing was performed with a retained kit of lot 04508be00 (lot 04508be00 and lot 04508be01 are identical, except of china specific labeling) and results of this setup did not implicate that the sensitivity performance of the lot is negatively impacted.The reagent kit showed normal performance without false non-reactive results.The clinical sensitivity was also evaluated by testing two commercially available seroconversion panels (zeptometrix hiv 9016 and hiv 9018) on one instrument.The seroconversion panel results were compared to architect hiv ag/ab combo test (alinity i ag/ab combo is equivalent to architect hiv ag/ab combo) results provided by zeptometrix and the reagent lot detected the same bleeds as reactive.Based on these data it was shown that the sensitivity performance of the lot is not impacted.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 04508be01.

• 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: 9578073
• MDR Text Key: 220987244
• Report Number: 3002809144-2020-00040
• 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: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2020
• Device Catalogue Number: 08P07-77
• Device Lot Number: 04508BE01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2020
• 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)