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

Model Number 07P5121

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Event 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.

Manufacturer Narrative

Section d.4 lot updated from unknown to lot 23304ui00.Section d.4 lot updated from unknown to lot 23304ui00.

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
• Type of Device: 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
• MDR Text Key: 284142725
• Report Number: 3005094123-2021-00221
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00380740160616
• UDI-Public: 00380740160616
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 11/23/2021; 12/18/2021
• Supplement Dates FDA Received: 12/02/2021; 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(4).; ALNTY I PROCESSING MODU, 03R65-01, (B)(4).; ALNTY I PROCESSING MODU, 03R65-01,(B)(4).