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

Model Number	7K78-30
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
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 a false positive b-hcg result generated on an architect i2000sr analyzer on an (b)(6) old female patient with abdominal pain.The initial result = 1770.58 miu/ml; repeat result = <1.20 miu/ml (customer provided reference range <5.00 miu/ml).There was no impact to patient management reported.
Additional Manufacturer Narrative
Patient #2 section a2 age at time of event: 45 years old, section a3 gender: female.Patient #3 section a2 age at time of event: 61 years old, section a3 gender: female.Section b date of event for patient 2 is (b)(6) 2021 and patient 3 is (b)(6) 2021 additional information in section b5.The complaint investigation included review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history review, field data review, and inhouse testing of a retained kit of lot 22493ui03.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history review for lot 22493ui03 did not identify any non-conformances or deviations.Inhouse testing of a retained reagent kit of the likely cause lot determined that all validity and acceptance criteria have been met demonstrating the lot is performing as expected.The overall performance of architect b-hcg reagents in the field was reviewed using data gathered from customers worldwide.The median value for the complaint lot is within established limits and comparable to other lots in the field.Labeling was reviewed and found to adequately address the issue under review.No systemic issue or deficiency with the architect total b-hcg reagent lot 22493ui03 was identified.Corrected information in section d4 catalog no, lot no., and unique identifier (udi) # and h4 device mfg date.
Event or Problem Description
Additional results for two more patients with a false positive b-hcg result generated on an architect i2000sr analyzer received from the customer.Patient 2: 45 -year-old female with abnormal uterine bleeding; initial result = 1139.95 miu/ml (positive); repeat result = <1.20 miu/ml (negative).The sample was tested on another architect analyzer (isr62968) = <1.20 miu/ml patient 3: 61-year-old female with malignant cervical tumor; initial result = 30.36 miu/ml (positive); repeat result = 1.32 miu/ml (negative) there was no impact to patient management reported.

• Brand Name: ARCHITECT 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
• MDR Report Key: 12547018
• Report Number: 3005094123-2021-00186
• Device Sequence Number: 4053934
• Product Code: DHA
• UDI-Device Identifier: 00380740014971
• UDI-Public: 00380740014971
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2021

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: 11/23/2021
• Device Model Number: 7K78-30
• Device Catalogue Number: 07K78-77
• Device Lot Number: 22493UI03
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 10/02/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 10/26/2021
• 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: ARC I2000SR INST, 03M74-02, ISR63149; ARC I2000SR INST, 03M74-02, ISR63149; ARC I2000SR INST, 03M74-02, ISR63149
• Patient Age: 18 YR