MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I TOTAL B-HCG REAGENT KIT; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Catalog Number	07P51-21
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a false positive alinity i total b-hcg for one patient that was not reported out of the laboratory.The following results were provided (reference range 5 - 24.99 miu/ml): initial result= 26.2 miu/ml; repeat result= <2 miu/ml results were confirmed on the other analyzer.There was no impact to patient management reported.
Additional Manufacturer Narrative
Complete entry for section a1 - patient identifier: (b)(6).Additional patient information added to section b5 - describe event or problem.
Event or Problem Description
The customer observed a false positive alinity i total b-hcg for one patient that was not reported out of the laboratory.The following results were provided (reference range 5 - 24.99 miu/ml): sid (b)(6), (b)(6) 2024, initial result= 26.2 miu/ml; repeat result= <2 miu/ml results were confirmed on the other analyzer.Update: additional information was provided on 02sept2024.Sid (b)(6), (b)(6) 2024, initial b-hcg result= 8.50 miu/ml; repeat result <2.42 miu/ml.Sid (b)(6), (b)(6) 2024, initial b-hcg result= 10.04 miu/ml; repeat result <2.42 miu/ml.Sid (b)(6), (b)(6) 2024, initial b-hcg result= 11.61 miu/ml; repeat result <2.42 miu/ml.Sid (b)(6), (b)(6) 2024, initial b-hcg result= 7.00 miu/ml; repeat result <2.42 miu/ml.There was no impact to patient management reported.
Event or Problem Description
The customer observed a false positive alinity i total b-hcg for one patient that was not reported out of the laboratory.The following results were provided (reference range 5 - 24.99 miu/ml): sid (b)(6), on (b)(6) 2024, initial result= 26.2 miu/ml; repeat result= <2 miu/ml; results were confirmed on the other analyzer.There was no impact to patient management reported.
Additional Manufacturer Narrative
Update to section a1 - patient identifier from multiple to (b)(6).Update to section b5 - describe event or problem, upon further investigation, the additional patient data is no longer reportable due to gray zone results.Update to section h4 - device mfg date from 3/15/2024 to 3/14/2024.The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, in house testing and labeling review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.The search for similar complaints for lot 62017ud00 did not identify an increase in complaint activity for the issue.The ticket trending review did not identify any trend regarding commonalities for lot number 62017ud00 and issue.Device history review did not identify any related nonconformances, potential nonconformances or deviations associated with the lot number 62017ud00 and complaint issue.In house accuracy testing was completed with a retained kit of the complaint lot.All validity and acceptance criteria were met during completion of the protocol, demonstrating that the lot is performing as expected.Labelling was reviewed which adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency of the alinity i total b-hcg reagent, lot 62017ud00 was identified.

• Brand Name: ALINITY I TOTAL B-HCG REAGENT KIT
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 19763902
• Report Number: 3005094123-2024-00380
• Device Sequence Number: 15581742
• Product Code: DHA
• UDI-Device Identifier: 00380740160616
• UDI-Public: (01)00380740160616(17)250123(10)62017UD00
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2024

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: 01/23/2025
• Device Catalogue Number: 07P51-21
• Device Lot Number: 62017UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 09/02/2024; 10/16/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/03/2024; 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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 I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Patient Sex: Unknown