MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I ANTI-HBC II REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 07P87-77

Device Problem False Negative Result (1225)

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

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

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, alinity i (b)(6) ii, list 7p87, that has a similar product distributed in the us, (b)(6), list number 7p84.Patient information: no further information was provided.Postal code: complete entry = (b)(6).

Event Description

The customer obtained a false non-reactive alinity i (b)(6) result for a (b)(6) year old female patient.The sample generated 0.200 s/co on the alinity and when tested on an alternate method generated a positive result of 1.082 s/co.No impact to patient management was reported.

Manufacturer Narrative

Section d4: catalog number changed from 07p87-32 to 07p87-77.Section d4: lot number changed from 18443be00 to 18443be01.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and testing of retained kits of the complaint lot number.Return testing was not completed as returns were not available.Review of complaint activity, trending reports and manufacturing documentation did not identify any issues or trends.A retained reagent kit containing the same bulk material as the complaint lot was tested in a sensitivity setup.All the reagent kit showed normal performance without false non-reactive results.The reagent kit showed normal performance without false non-reactive results.Additionally, the clinical sensitivity of the lot was evaluated by testing two commercially available seroconversion panels with the retained kit.The seroconversion panel results were compared to the architect anti-hbc ii test results provided by the panel manufacturer.The lot detected the same bleeds as reactive for the seroconversion panels.The sensitivity performance of the complaint lot is not negatively impacted.Based on our investigation, no systemic issue or deficiency with the alinity i anti-hbc ii reagent lot was identified in the complaint.H4 device mfg date changed from 7/28/2020 to 7/30/2020 due to an incorrect entry.

Event Description

The customer obtained a false non-reactive alinity i anti-hbc result for a 64 year old female patient.The sample generated 0.200 s/co on the alinity and when tested on an alternate method generated a positive result of 1.082 s/co.No impact to patient management was reported.

• Brand Name: ALINITY I ANTI-HBC II REAGENT KIT
• Type of Device: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10898445
• MDR Text Key: 241306465
• Report Number: 3002809144-2020-01143
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2021
• Device Catalogue Number: 07P87-77
• Device Lot Number: 18443BE01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, AI04027; ALNTY I PROCESSING MODU, 03R65-01, AI04027; ALNTY I PROCESSING MODU, 03R65-01, AI04027
• Patient Age: 64 YR