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

Catalog Number 06P06-55

Device Problem False Positive Result (1227)

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

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information: patient identifier: (b)(6).Patient information: no further patient information was provided by the customer.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 6p06-55 that has a similar product distributed in the us, list number 6p06-60.

Event Description

The customer observed false repeat reactive alinity s (b)(6) results for eight samples.The following data was provided: (b)(6).No impact to patient management was reported.

Manufacturer Narrative

The initial emdr was submitted with the incorrect product code in error.The product code in section d2 was changed from lom to qhm.The evaluation of complaint data for the product and likely cause alinity s anti-hbc lot 09227be00 identified normal complaint activity there are no trends for the product related to patient results.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 and the data shows that the specificity performance of lot 09227be00 is not compromised.Customer sample returns did not pass the acceptance criteria confirming the elevated sample specific results.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 likely cause lot did not identify any issues associated with the complaint issue.The performance of the likely cause lots were investigated by completing a review for non-conformance's, potential non-conformance's and deviations related to the likely cause lot.This review did not identify any non-conformance's, potential non-conformance's or deviations.A review of labeling concluded that the issue is sufficiently addressed.No product deficiency was identified.

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
• Type of Device: ANTI-HBC
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10084048
• MDR Text Key: 199537623
• Report Number: 3002809144-2020-00411
• 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,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: 11/09/2020
• Device Catalogue Number: 06P06-55
• Device Lot Number: 09227BE00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 05/22/2020
• Supplement Dates Manufacturer Received: 06/09/2020; 08/31/2020
• Supplement Dates FDA Received: 06/16/2020; 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; ALINITY S SYSTEM, LIST 06P16-01.; SERIAL (B)(6).; SERIAL (B)(6).; SERIAL (B)(6).