MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I2000SR PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03M74-02
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed false positive alinity i b-hcg results on a 20yrs old female patient.The results provided were: on (b)(6) 2026 initial=208.36 miu/ml (> 25.0 miu/ml =positive) /repeated =< 1.2 miu/ml (< or =5.0 miu/ml=negative).At other hospital hcg=negative (no actual results provided).There was no reported impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
During the requested site visit, the field service engineer (fse) found a reddish-brown sediment at the bottom of the reservoir, buffer.Fse cleaned the reservoir, buffer (rohs), which resolved the issue.The service history of the architect i2000sr, serial number (b)(6) found no additional discrepant patient results were reported after the current event was identified.A review of historical data revealed no trends, systemic issues, or related nonconformances.A review of trending data associated with the reservoir, buffer (rohs), did not identify an increase in complaint activity.The architect system operations manual addresses operational precautions and limitations; component replacement; and troubleshooting for erratic results.The architect i2000sr service and support manual contained adequate information for troubleshooting erratic results on the architect system.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Based on the investigation, no product deficiency was identified for the architect i2000sr, serial number (b)(6) or reservoir, buffer (rohs).
Event or Problem Description
The customer observed false positive alinity i b-hcg results on a 20yrs old female patient.The results provided were: on (b)(6) 2026 initial=208.36 miu/ml (> 25.0 miu/ml =positive) /repeated =< 1.2 miu/ml (< or =5.0 miu/ml=negative).At other hospital hcg=negative (no actual results provided).There was no reported impact to patient management.

• Brand Name: ARCHITECT I2000SR 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: 24568129
• Report Number: 3016438761-2026-00128
• Device Sequence Number: 21222786
• Product Code: JJE
• UDI-Device Identifier: 00380740006235
• UDI-Public: (01)00380740006235
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/02/2026

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: 03M74-02
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2016
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC BHCG 100T (CN), 07K78-74, (B)(6).; ARC BHCG 100T (CN), 07K78-74, (B)(6).
• Patient Age: 20 YR
• Patient Sex: Female