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

Catalog Number 07P51-74

Device Problem False Negative Result (1225)

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

Event Date 05/23/2022

Event Type  malfunction  

Manufacturer Narrative

Patient identifier sid=(b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false negative alinity i total (b)(6) results on one female patient.The results provided were: on (b)(6) 2022 sid (b)(6) initial=5.01iu/l (>5.0 miu/ml and < 25.0 miu/ml will be no interpretation; grayzone) /repeated = 4.98 miu/ml (< or =5.0 miu/ml=negative) / gestational sac could be clearly observed on b-mode ultrasound /specimen send out for external testing=3.7 miu/ml there was no reported impact to patient management.

Manufacturer Narrative

The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review of alinity i total b-hcg reagent lot 31044ud01.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of complaints determined that there are no trends for the product for the complaint issue.The ticket trending review of at least 12 months complaint data for the likely cause list number does not identify any adverse or non-statistical trend.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.In-house testing of a retained reagent kit of the complaint lot could not be performed as the lot has expired.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity i total b-hcg reagent lot number 31044ud01.Updated section d3 email address for medical device contact person and g1 manufactures site email to (b)(4).

Event Description

The customer observed false negative alinity i total b-hcg results on one female patient.The results provided were: on (b)(6) 2022 sid (b)(6) initial=5.01iu/l (>5.0 miu/ml and < 25.0 miu/ml will be no interpretation; grayzone) /repeated = 4.98 miu/ml (< or =5.0 miu/ml=negative) / gestational sac could be clearly observed on b-mode ultrasound /specimen send out for external testing=3.7 miu/ml there was no reported impact to patient management.

• 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 N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14658798
• MDR Text Key: 296167929
• Report Number: 3005094123-2022-00121
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

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: 07/19/2022
• Device Catalogue Number: 07P51-74
• Device Lot Number: 31044UD01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: 08/17/2022
• Supplement Dates FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Sex: Female