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

Catalog Number	07K78-30
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated that a false positive architect total b-hcg result of 4,494 iu/l was contested by the patient (b)(6) who had retesting performed at another laboratory where the result was negative.The customer retested the archived patient sample and the result was negative.The customer stated that the patient sample tested prior to the sample in question had a very high b-hcg result of 75,000 iu/l; therefore, sample carryover is suspected.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
Trending review determined no trend for the issue for the product.Device history record review did not show any potential non-conformances or deviations.Labeling was reviewed and found to adequately address the issue under review.Accuracy testing was completed using panels which mimic patient samples using an in-house retained kit of architect total b-hcg reagent lot number 45625ud00.All specifications were met indicating that the lot is performing acceptably.Based on the investigation, no deficiency for lot number 45625ud00 was identified.
Event or Problem Description
The customer stated that a false positive architect total b-hcg result of 4,494 iu/l was contested by the patient (id (b)(6)) who had retesting performed at another laboratory where the result was negative.The customer retested the archived patient sample and the result was negative.The customer stated that the patient sample tested prior to the sample in question had a very high b-hcg result of 75,000 iu/l; therefore, sample carryover is suspected.No impact to patient management was reported.

• Brand Name: ARCHITECT 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: 18256861
• Report Number: 3005094123-2023-00349
• Device Sequence Number: 12527546
• Product Code: DHA
• UDI-Device Identifier: 00380740014971
• UDI-Public: 00380740014971
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K983424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

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: 01/03/2024
• Device Catalogue Number: 07K78-30
• Device Lot Number: 45625UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2023
• 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: ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Sex: Unknown