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	12/12/2023
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.
Event or Problem Description
The customer observed false positive alinity i total b-hcg result for a female patient who is being followed for a miscarriage.The customer noticed that the result did not match the patient¿s history and reran the same sample.The repeated results were negative.The customer notified the physician and the result was corrected.To ensure the correct result for the patient, the physician ordered an ultrasound and another blood draw.The customer stated the patient has not had the ultrasound.The patient¿s new blood sample generated a negative result.The following data was provided: (b)(6) 2023 sid (b)(6) initial result = 127.33 miu/ml (positive).Repeat results = 2.93 miu/ml (negative) and 3.10 miu/ml (negative).(b)(6) 2023 (new blood draw) result = < 3 miu/ml (negative).Patient¿s previous result ( (b)(6) 2023) = 50.0 miu/ml (positive).No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for false positive alinity i total -hcg result included a review of data and information provided by the customer, ticket trending review, device history record review, field data review, and labeling review.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and support the complaint issue.A ticket search by lot indicates that the reagent lot performs as expected for this product.A review of the complaint trending report did not identify any trends for the issue for the product.A review of the device history record did not identify any non-conformances or deviations with the lot number 55143ud00 and the complaint issue.The overall performance of the alinity i total -hcg reagents in the field was reviewed using data gathered from customers worldwide.The median value (for the negative population) for the complaint lot is within the established limits.A review of labeling was performed and found to sufficiently address the customer's issue.Based on this investigation, no systemic issue or deficiency was identified for the alinity i total -hcg reagent lot 55143ud00.
Event or Problem Description
The customer observed false positive alinity i total b-hcg result for a female patient who is being followed for a miscarriage.The customer noticed that the result did not match the patient¿s history and reran the same sample.The repeated results were negative.The customer notified the physician and the result was corrected.To ensure the correct result for the patient, the physician ordered an ultrasound and another blood draw.The customer stated the patient has not had the ultrasound.The patient¿s new blood sample generated a negative result.The following data was provided: (b)(6) 2023 sid (b)(6) initial result = 127.33 miu/ml (positive).Repeat results = 2.93 miu/ml (negative) and 3.10 miu/ml (negative).(b)(6) 2023 (new blood draw) result = < 3 miu/ml (negative) patient¿s previous result ((b)(6) 2023) = 50.0 miu/ml (positive) no impact to patient management was reported.

• 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: 18441461
• Report Number: 3005094123-2024-00009
• Device Sequence Number: 20869371
• Product Code: DHA
• UDI-Device Identifier: 00380740160616
• UDI-Public: 00380740160616
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 02/24/2024

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: 07/05/2024
• Device Catalogue Number: 07P51-21
• Device Lot Number: 55143UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2023
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• 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)
• Patient Sex: Female