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

Catalog Number	03M74-01
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
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.Complete information for section a1 patient identifier is (b)(6) and (b)(6).
Event or Problem Description
The customer observed a false positive architect total b-hcg result for one patient.The result was not reported out.The following data was provided: sid (b)(6) processed on (b)(6)2024 initial result = 838.9 miu/ml new sample processed on (b)(6) 2024 sid (b)(6) same patient = <1.2 miu/ml sid (b)(6) primary and secondary tube repeated on (b)(6)2024 = <1.2 miu/ml for both tubes.No impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the module, performed troubleshooting including replacement of the fitting kit, trigger_pre-trigger (rohs) (7-77664-02) and decontaminated the instrument surface.Part replacement resolved the issue.No additional discrepant result issues have been reported since the service activity was completed.The fitting kit, trigger_pre-trigger (rohs) (7-77664-02) was determined the likely cause of the result issue.The instrument service history review revealed no additional service tickets associated with discrepant/erratic results.There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of tracking and trending of the architect i2000sr processing module and the fitting kit, trigger _pre-trigger (rohs) (7-77664-02) did not identify any trends associated with the complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect i2000sr, serial # (b)(6) or the fitting kit, trigger _pre-trigger (rohs) (7-77664-02) was identified.
Event or Problem Description
The customer observed a false positive architect total b-hcg result for one patient.The result was not reported out.The following data was provided: sid (b)(6) processed on (b)(6) 2024 initial result = 838.9 miu/ml new sample processed on (b)(6) 2024 sid (b)(6) same patient = <1.2 miu/ml sid (b)(6) primary and secondary tube repeated on (b)(6) 2024 = <1.2 miu/ml for both tubes.No impact to patient management was reported.

• Brand Name: ARCHITECT I2000SR
• 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: 20882489
• Report Number: 3016438761-2024-00713
• Device Sequence Number: 9043320
• Product Code: JJE
• UDI-Device Identifier: 00380740023386
• UDI-Public: (01)00380740023386
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• 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): 01/14/2025

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: 03M74-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2005
• 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), 07K78-25, 64271UD00; ARC BHCG RGT (100T), 07K78-25, 64271UD00; FITTING KIT, TRIGGER_PRE-TRIGGER (ROHS), 7-77664-0; FITTING KIT, TRIGGER_PRE-TRIGGER (ROHS), 7-77664-0
• Patient Sex: Unknown