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 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information: patient identifier: r0001190379327.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 reactive alinity s anti-hbc results for 1 sample on alinity serial number (b)(4).The following data was provided (units of measure = s/co, results >/= 1.00 = reactive): sid r0001190379327 initial result = 1.23, repeat = 1.18, repeated with different reagent serial number on same alinity analyzer serial number (b)(4) = 0.09, repeat on serial number (b)(4) = 0.39.No impact to patient management was reported.

Manufacturer Narrative

A review of tickets was performed for reagent lot number 01763be00.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Field data was reviewed, allowing the conclusion that the issues only occur with individual cartridges and that there is no general issue for the lot.Affected cartridges of the issue show increases in negative control values over time.A retained kit of alinity s anti-hbc reagent lot number 07163be00 was calibrated and the calibration met instrument specifications.All control values met control specifications and were in the typical range.Specificity testing was performed using 220 panel members of a human negative population panel.All panel members were nonreactive, and no false reactive results were obtained.Further additional replicates of the negative control were tested which all met specifications.Precision was evaluated by testing several replicates of alinity s anti-hbc controls.All generated data demonstrates that the performance of lot number 0176be00 is not compromised regarding the complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the alinity s anti-hbc for reagent lot 01763be00 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: 9197263
• MDR Text Key: 190159239
• Report Number: 3002809144-2019-00649
• Device Sequence Number: 1
• Product Code: LOM
• 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: 09/22/2020

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: 02/05/2020
• Device Catalogue Number: 06P06-55
• Device Lot Number: 01763BE00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 12/12/2019; 09/21/2020
• Supplement Dates FDA Received: 12/16/2019; 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY S ANALYZER, LIST 06P16-01.; ALINITY S ANALYZER, LIST 06P16-01.; ALINITY S ANALYZER, LIST 06P16-01.; SERIAL (B)(6).; SERIAL (B)(6).; SERIAL (B)(6).