MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I1000SR PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	01L86-01
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1: patient identifier: sample ids: (b)(6).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 architect total hcg result generated by the architect i1000sr processing module for three patients.The samples were repeated, and negative results were obtained.The following data was provided (= 5.00 miu/ml is negative, >5.00 to <25.00 miu/ml is grayzone, = 25.00 miu/ml is positive): sid: (b)(6): on (b)(6) 2025 initial result = 31.32 miu/ml (positive).On (b)(6) 2023 repeat result = < 1.20 miu/ml (negative).Sid: (b)(6): on (b)(6) 2025 initial result = 2.99 miu/ml (negative).On (b)(6) 2025 repeat results = 30.03 miu/ml (positive), 7.69 miu/ml (grayzone), < 1.20 miu/ml (negative).Sid: (b)(6): on (b)(6) 2025 initial result = 47.48 miu/ml (positive).On (b)(6) 2025 repeat results = 19.05 miu/ml (positive), < 1.20 miu/ml (negative).There was no impact to patient management reported.
Event or Problem Description
The customer observed false positive architect total -hcg result generated by the architect i1000sr processing module for three patients.The samples were repeated, and negative results were obtained.The following data was provided (= 5.00 miu/ml is negative, >5.00 to <25.00 miu/ml is grayzone, = 25.00 miu/ml is positive): sid (b)(6).(b)(6) 2025 initial result = 31.32 miu/ml (positive) (b)(6) 2023 repeat result = < 1.20 miu/ml (negative) sid (b)(6): (b)(6) 2025 initial result = 2.99 miu/ml (negative) (b)(6) 2025 repeat results = 30.03 miu/ml (positive), 7.69 miu/ml (grayzone), < 1.20 miu/ml (negative) sid (b)(6): (b)(6) 2025 initial result = 47.48 miu/ml (positive) (b)(6) 2025 repeat results = 19.05 miu/ml (positive), < 1.20 miu/ml (negative) there was no impact to patient management reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the instrument, performed extensive troubleshooting, and determined that the washzone temperature tubing/sensor was the likely cause of the issue.The fsr replaced the part, and the issue was resolved.An instrument service history review for the architect i1000sr, serial number (b)(6), revealed no additional service tickets related to false positive total b-hcg results.A review of complaint and trending data for the architect i1000sr processing module did not identify any similar issues as described in this complaint.Additionally, a review of complaint and trending data associated with the washzone temperature tubing/sensor did not identify an increase in complaint activity.The device history record was reviewed, and no non-conformances or potential non-conformances were identified.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the architect i1000sr processing module, serial number (b)(6), or the washzone temperature tubing/sensor was identified.

• Brand Name: ARCHITECT I1000SR PROCESSING MODULE
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 22017896
• Report Number: 3016438761-2025-00287
• Device Sequence Number: 13132718
• Product Code: JJE
• UDI-Device Identifier: 00380740001537
• UDI-Public: (01)00380740001537
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 07/17/2025

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 Catalogue Number: 01L86-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2013
• 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 BHCG RGT 100T, 06C21-26, UNKNOWN; ARC BHCG RGT 100T, 06C21-26, UNKNOWN
• Patient Sex: Unknown