MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S ANTI-HBC REAGENT KIT; HEPATITIS B VIRUS CORE ANTIGEN (E COLI, RECOMBINANT)

Catalog Number	06P06-60
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed false reactive alinity s anti-hbc results when compared to another method.There were 11 repeat reactive alinity s anti-hbc samples.The samples were run using different methodology (ortho hbc elisa assay) and only 3 out of the 11 samples were positive.No impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Evaluation of complaint data for the product did not identify an increase in complaint activity for the complaint issue.Return testing was not performed as returns were not available.Device history record review was performed on lot 50519be00, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends.A review of field data for alinity s anti-hbc was performed.Overall reactive rates of ln 6p06-60, lot 50519be00, across bloodworks northwest (usa), applicable peer sites and across a whole blood and plasma screening monitoring group were collected and assessed.Across the whole blood and plasma monitoring group, the customer and their peer sites, the performance of lot 50519be00 is within product requirements and comparable to other lots analyzed in the comparison.Whole blood and plasma monitoring group: lot 50519be00: irr: 0.342%, rrr: 0.336%, irr - rrr: 0.006%, specificity: 99.664%.At bloodworks northwest (usa), the performance of lots 49219be00 and 50519be00 is slightly lower than peers but within product requirements and comparable to previous lots used at the customer site.Lot 50519be00: irr: 0.475%, rrr: 0.466%, irr - rrr: 0.009%, specificity: 99.534%.Peer sites: lot 50519be00: irr: 0.306%, rrr: 0.298%, irr - rrr: 0.008%, specificity: 99.702%.A review of labeling concluded that the issue is sufficiently addressed.Based on this investigation, the alinity s anti-hbc reagent kit, ln 6p06-60, lot 50519be00 is performing as expected.Based on the information within the complaint record, the devices met performance specifications at the customer site.Further, a systemic issue and/or product deficiency was not identified.
Event or Problem Description
The customer observed false reactive alinity s anti-hbc results when compared to another method.There were 11 repeat reactive alinity s anti-hbc samples.The samples were run using different methodology (ortho hbc elisa assay) and only 3 out of the 11 samples were positive.Additional information received from the customer.The following results were provided: sid (b)(6) 5.48 / 5.51 / 5.25, alt assay 3.274 / 6.723, sid (b)(6) 2.89 / 2.84 / 2.77, alt assay 1.358 / 2.789, sid (b)(6) 1.86 / 1.92 / 1.93, alt assay 0.103 / 0.211, sid (b)(6) 1.02 / 1.00 / 0.98, alt assay 0.090 / 0.185, sid (b)(6) 1.61 / 1.56 / 1.59, alt assay 0.455 / 0.934, sid (b)(6) 1.02 / 1.02 / 1.07, alt assay 0.649 / 1.333, sid (b)(6) 1.42 / 1.44 / 1.43, alt assay 0.094 / 0.193, sid (b)(6) 1.07 / 1.03 / 1.02, alt assay 0.084 / 0.172, sid (b)(6) 1.10 / 0.98 / 1.07, alt assay 0.088 / 0.181, sid (b)(6) 1.09 / 1.03 / 1.11, alt assay 0.094 / 0.193, sid (b)(6) 1.64 / 1.67 / 1.64, alt assay 0.440 / 0.903.No impact to patient management was reported.

• Brand Name: ALINITY S ANTI-HBC REAGENT KIT
• Common Device Name: HEPATITIS B VIRUS CORE ANTIGEN (E COLI, RECOMBINANT)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18250636
• Report Number: 3002809144-2023-00484
• Device Sequence Number: 20630887
• Product Code: QHM
• UDI-Device Identifier: 00380740117207
• UDI-Public: 00380740117207
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: BL125681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/02/2024
• Device Catalogue Number: 06P06-60
• Device Lot Number: 50519BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY S SYSTEM, 06P16-01, AS1264; ALNTY S SYSTEM, 06P16-01, AS1264
• Patient Sex: Unknown