MAUDE Adverse Event Report: A.I.D.D LONGFORD ALINITY I TOTAL B-HCG REAGENT KIT; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Model Number	07P5121
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem Description
The account stated discrepant alinity i total bhcg results were observed between the alinity i processing module and instrument manager laboratory information system (lis).The account stated 6 patient samples results of alinity i total bhcg <2.42 miu/ml were sent from the alinity i processing module to the lis but the same results in the lis were >15,000 miu/ml.The correct patient results are positive >15,000 miu/ml.Through troubleshooting, it was discovered the issue was due to configuration parameters in alinity i processing module.After the adjustment of the configuration parameters (linearity retest results, calculations for standard dilutions, reportable ranges) the correct alinity i total bhcg results were sent to the lis.No specific patient information was provided.No impact to patient management was reported.
Additional Manufacturer Narrative
Section d.4 lot updated from unknown to lot 23304ui00.Section d.4 lot updated from unknown to lot 23304ui00.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed to alinity i processing module, list 3r65-01 and submitted under manufacturer report number 3016438761-2022-00020-00.All further information will be documented under mdr number 3016438761-2022-00020.Section g1: contact office name, address, email, phone, fax updated.

• Brand Name: ALINITY I TOTAL B-HCG REAGENT KIT
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford, IL N39 E-932 ; 2246682940
• MDR Report Key: 12857882
• Report Number: 3005094123-2021-00221
• Device Sequence Number: 5082247
• Product Code: DHA
• UDI-Device Identifier: 00380740160616
• UDI-Public: 00380740160616
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2022

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: 11/25/2021
• Device Model Number: 07P5121
• Device Catalogue Number: 07P51-21
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 11/23/2021; 12/18/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 12/02/2021; 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• 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)(4).; ALNTY I PROCESSING MODU, 03R65-01, (B)(4).; ALNTY I PROCESSING MODU, 03R65-01,(B)(4).
• Patient Sex: Unknown