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 Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The account generated false positive alinity i total bhcg results on a presurgical patient sample for hysterectomy.On (b)(6) 2022, sid (b)(6) (71 year old female, non-hispanic/latino, race not provided) generated alinity i total bhcg positive of 115.90, 114.31 miu/ml and on alternate alinity analyzer (serial (b)(4) positive of 133.21 miu/ml.The patient tested vitros hcg negative <3 miu/ml and cardinal qual hcg combo urine negative.The account stated there was no adverse impact to patient care.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The ticket search by lot indicate that the likely cause lots perform as expected for this product.The ticket trending review of complaint data for the likely cause list number does not identify any related adverse trend.Labeling review concludes that the issue is adequately addressed.A review in the corrective and preventive actions system does not identify any related non-conformances or deviations associated with the likely cause lot numbers.The overall performance of alinity i total b-hcg complaint reagent lots in the field was reviewed using data gathered from customers worldwide.The medians values of the negative population are within the established limits and comparable to historical reagent lot performance.No product deficiency was identified.This follow up includes a correction to include the codes in section h6 for component code, type of investigation, investigation findings and investigation conclusions that were not included in the initial report.

• 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 N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15086406
• Report Number: 3005094123-2022-00154
• Device Sequence Number: 4055637
• Product Code: DHA
• UDI-Device Identifier: 00380740160616
• UDI-Public: 00380740160616
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 09/12/2022

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: 12/04/2022
• Device Model Number: 07P5121
• Device Catalogue Number: 07P51-21
• Device Lot Number: 35052UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2022
• 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 MOD, 03R65-01, (B)(6) ; ALNTY I PROCESSING MOD, 03R65-01, (B)(6) ; ALNTY I TTL BHCG 1200T-, 07P51-31, 33512UD00; ALNTY I TTL BHCG 1200T-, 07P51-31, 33512UD00
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic