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

Model Number 7K78-25

Device Problem False Negative Result (1225)

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

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: sample id (b)(6), sample id (b)(6), sample id (b)(6) (all sample ids belong to the same patient).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer obtained a false negative architect total b-hcg result for a patient while running on the architect i2000sr analyzer.The following data was provided (reference range: < 5.00 miu/ml is negative, > 25.00 miu/ml is positive): sample id (b)(6) 87.38 miu/ml (positive).Sample id (b)(6) (new sample taken a few days later) = < 1.2 miu/ml (negative) / retested.Sample = 234.55 miu/ml (positive).Sample id (b)(6) (new sample taken a few days after the 2nd sample) = 352.24 miu/ml (positive).The field service representative arrived onsite to troubleshoot the issue and ran the 3 samples in 5 replicates and generated results all consistent with previous runs with no negative result obtained.The 2nd sample was retested and generated a positive result.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for a false negative architect total b-hcg result included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.The lot search review did not identify an increase in complaint activity for the issue for the lot.The trending review determined no trends were identified for the product for the issue.Review of the field data for the positive population by reagent lot indicates lot 23292ui00 is within the established limits and is comparable with other lots in the field, indicating the lot is performing acceptably.Device history record review on lot 23292ui00 did not identify any non-conformances or deviations associated with the customer¿s observation.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect total b-hcg, reagent lot 23292ui00 was identified.

Manufacturer Narrative

D4 - lot no initial: unknown / updated: 23292ui00 d4 - expiration date initial: unknown / updated: 01/04/2022 h4 - device mfg date initial: unknown / updated: 02/13/2021.

• Brand Name: ARCHITECT 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
• MDR Report Key: 12203354
• MDR Text Key: 263551061
• Report Number: 3005094123-2021-00137
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 00380740014964
• UDI-Public: 00380740014964
• Combination Product (y/n): N
• PMA/PMN Number: K983424
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2022
• Device Model Number: 7K78-25
• Device Catalogue Number: 07K78-25
• Device Lot Number: 23292UI00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2SR REFURB-SEKAT, 03M74-97, ISR07463.; ARC I2SR REFURB-SEKAT, 03M74-97, ISR07463.; ARC I2SR REFURB-SEKAT, 03M74-97, ISR07463.