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	02/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a false positive architect total b-hcg result generated on the architect i2000sr analyzer.The following data was provided: sid (b)(6) (46-year-old female): initial result = 32.41 miu/ml (this result was released and questioned by the physician).Repeat result from same sample = 0.36 miu/ml.Retest from a new blood draw from the patient = 0.00 miu/ml (reference range: 225000.Carryover from the high-value samples led to the false positive b-hcg result for this sample in question.The customer was instructed by abbott customer service to replace the sample probe and conduct a contamination test on high-value samples was performed and passed.There was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The field service representative (fsr) found the two samples prior to the false positive result, generated high-value b-hcg results.The arc, probe (list number 08c94-47) was replaced due to possible carryover on the architect i2000sr, serial number (b)(6).A carryover study was performed after replacement of the arc, probe and the results yielded acceptable results.The part replacement resolved the issue.The service history for the (b)(6) verifies no subsequent false positive b-hcg results have been reported since the current issue was identified.A review of tracking and trending did not identify any trends for the arc, probe (list number 08c94-47).A review of tracking and trending did not identify any trends for the architect i2000sr with regard to the complaint issue.The manufacturing documentation was reviewed and did not identify any nonconformances associated with the complaint issue.The architect system operations manual adequately addresses operational precautions and limitations; component replacement; and troubleshooting for erratic results.Based on the investigation, no systemic issue or product deficiency of the architect i2000sr for serial (b)(6), or the arc, probe was identified.
Event or Problem Description
The customer reported a false positive architect total b-hcg result generated on the architect i2000sr analyzer.The following data was provided: sid (b)(6) (46-year-old female): initial result = 32.41 miu/ml (this result was released and questioned by the physician) repeat result from same sample = 0.36 miu/ml retest from a new blood draw from the patient = 0.00 miu/ml (reference range: 225000.Carryover from the high-value samples led to the false positive b-hcg result for this sample in question.The customer was instructed by abbott customer service to replace the sample probe and conduct a contamination test on high-value samples was performed and passed.There was no impact to patient management reported.

• 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: 24447188
• Report Number: 3016438761-2026-00108
• Device Sequence Number: 10255084
• 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): 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): 03/11/2026

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: 02/14/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2019
• 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 100T (CN), 07K78-74, 80539UD00; ARC BHCG 100T (CN), 07K78-74, 80539UD00
• Patient Age: 46 YR
• Patient Sex: Female