MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S ANTI-HBC REAGENT KIT

Catalog Number 06P06-55

Device Problem False Positive Result (1227)

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

Event Date 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 06p06-55 that has a similar product distributed in the us, list number 06p06-60.Patient identifier: multiple = (b)(6).Patient information: no further information was provided.Review of complaint activity associated with reagent lot 09227be00 identified normal complaint activity.Tracking and trending reports associated with the alinity s (b)(6) assay determined there were no trends.A returned reagent kit cartridge from the customer was tested to determine the cysteamine hydrochloride content.Despite sample stress due to testing, storage and transport conditions the content of cysteamine hydrochloride remained within the acceptance criteria.Therefore, a reduction of the concentration of cysteamine hydrochloride caused by a possible contamination of the sample can be excluded.Additionally, a retained kit of reagent lot 09227be00 was tested for specificity with a human negative population panel.All panel members were non-reactive and no false reactive results were obtained.Therefore, the specificity performance of lot 09227be00 was not compromised.Return samples provided by the customer were tested in a time course study along with a negative control bulk material.While the results of the return samples replicated the events experienced at the site, indicating a sample subset interaction, the negative control in the study met all protocol criteria and product requirements.As the negative control is designed as representative of the expected negative donor population, the system is performing as intended and product requirements are being met.Manufacturing documentation for the reagent lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the available information and this investigation, no systemic issue or deficiency of the alinity s (b)(6) assay was identified.

Event Description

The customer obtained multiple false repeat reactive alinity s (b)(6) results.The customer indicated the samples generated negative results when tested on vidas and biorad assays.The following initial and repeat results for the alinity s (b)(6) assay were provided: sample id (b)(6): 1.24, 1.19 and 1.25 s/co; sample id (b)(6): 1.00, 1.06 and 0.98 s/co; sample id (b)(6): 1.67, 1.68 and 1.68 s/co; sample id (b)(6): 2.23, 2.17 and 2.32 s/co; sample id (b)(6): 2.51, 2.59 and 2.77 s/co; sample id (b)(6): 1.35, 1.33 and 1.37 s/co.No impact to patient/donor management was reported.

Manufacturer Narrative

This follow-up mdr is being submitted because this event involved an international product: alinity anti-hbc, list 06p06-55 which a field action, fa02sep2020 has been taken.There is no impact to the us similar product: list 06p06-60 and no further mdrs will be required.

• Brand Name: ALINITY S ANTI-HBC REAGENT KIT
• Type of Device: ANTI-HBC
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10179529
• MDR Text Key: 230615273
• Report Number: 3002809144-2020-00491
• Device Sequence Number: 1
• Product Code: QHM
• 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: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2020
• Device Catalogue Number: 06P06-55
• Device Lot Number: 09227BE00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY S SYSTEM, LIST 06P16-01,; ALINITY S SYSTEM, LIST 06P16-01,; SERIAL (B)(4); SERIAL (B)(4)