MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I TOTAL B-HCG REAGENT KIT; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Catalog Number	07P51-31
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a false positive alinity i total b-hcg result for a 19-year-old female patient.The following data was provided (reference range b-hcg: 5.00 and < 25.00 miu/ml is grayzone, >/= 25.00 miu/ml is positive): sid (b)(6): on (b)(6) 2023 initial b-hcg = 1204 miu/ml (positive); on (b)(6) 2023 point of care urine test = negative; on (b)(6) 2023 original sample repeated = 4 miu/ml (negative); previous historical result generated on (b)(6) 2023 was 44 miu/ml (positive).On (b)(6) 2023, the customer provided another case of a false positive alinity i total b-hcg result for a patient sample.The sample id (b)(6) generated an initial hcg result of 339 miu/ml; repeat result generated a value of < 1.20 miu/ml.The customer stated both patients were almost treated with methotrexate because doctors initially suspected ectopic pregnancy due to initial discrepant result.The customer confirmed the doctors did not treat the patients since repeat results were negative.There was no harm to the patients.There was no impact to patient management reported.
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6) ( 19-year old female) / (b)(6) (2 separate patients).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint investigation included a search for similar complaints, and the review of complaint text, trending data, labeling, in-house testing, and device history records.Return testing was not performed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The lot search review did not identify an increase in complaint activity for the issue.Ticket trending review did not identify any related trends for the product for the issue.A review of the device history record and did not identify any non-conformances or deviations associated with the reagent lot 53605ud00 and complaint issue.Accuracy testing was completed using panels which mimic patient samples using an in-house retained kit of the complaint lot stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Labeling was reviewed and concludes that the issue is adequately addressed.Based on the investigation, no systemic issue or product deficiency of the alinity i total b-hcg reagent lot 53605ud00 was identified.
Event or Problem Description
The customer reported a false positive alinity i total b-hcg result for a 19-year-old female patient.The following data was provided (reference range b-hcg: 5.00 and < 25.00 miu/ml is grayzone, >/= 25.00 miu/ml is positive): sid (b)(6): on (b)(6) 2023 initial b-hcg = 1204 miu/ml (positive); on (b)(6) 2023 point of care urine test = negative; on (b)(6) 2023 original sample repeated = 4 miu/ml (negative); previous historical result generated on (b)(6) 2023 was 44 miu/ml (positive).On (b)(6) 2023, the customer provided another case of a false positive alinity i total b-hcg result for a patient sample.The sample id (b)(6) generated an initial hcg result of 339 miu/ml; repeat result generated a value of < 1.20 miu/ml.The customer stated both patients were almost treated with methotrexate because doctors initially suspected ectopic pregnancy due to initial discrepant result.The customer confirmed the doctors did not treat the patients since repeat results were negative.There was no harm to the patients.There was no impact to patient management 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: 17928006
• Report Number: 3005094123-2023-00274
• Device Sequence Number: 15030653
• Product Code: DHA
• UDI-Device Identifier: 00380740160623
• UDI-Public: 00380740160623
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2023

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: 05/12/2024
• Device Catalogue Number: 07P51-31
• Device Lot Number: 53605UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2023
• 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: Unknown