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

Catalog Number	01L86-40
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a false positive architect stat high sensitive troponin-i result generated on the architect i1000sr instrument.The following data was provided (customer¿s normal reference range: 0.00-0.07 ng/ml): sid (b)(6): initial result = 0.108 ng/ml.Repeat on same analyzer = 0.068 ng/ml.Repeat on another analyzer (sn (b)(6) = 0.018 / 0.016 ng/ml.The positive troponin-i result was not reported to the patient¿s chart.The troponin-i test was an add on and the sample was sitting for 3 hours prior to testing.The customer inspected the instrument and discovered the pre-trigger and trigger solution volume was below 20%.The customer while changing the pre-trigger and trigger solution bottles, the opaque connector tubing broke off.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.A1- patient identifier: (b)(6) (complete sample id as the characters exceeded the allowable number in the field) all available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Updated d10 - concomitant product - arc troponin hs rgt 100, 02r98-25, 93900un24.
Event or Problem Description
The customer reported a false positive architect stat high sensitive troponin-i result generated on the architect i1000sr instrument.The following data was provided (customer¿s normal reference range: 0.00-0.07 ng/ml): sid (b)(6): initial result = 0.108 ng/ml.Repeat on same analyzer = 0.068 ng/ml.Repeat on another analyzer (sn (b)(6)) = 0.018 / 0.016 ng/ml.The positive troponin-i result was not reported to the patient¿s chart.The troponin-i test was an add on and the sample was sitting for 3 hours prior to testing.The customer inspected the instrument and discovered the pre-trigger and trigger solution volume was below 20%.The customer while changing the pre-trigger and trigger solution bottles, the opaque connector tubing broke off.There was no impact to patient management reported.
Additional Manufacturer Narrative
When troubleshooting the issue service observed the fitting kit, trigger_pre-trigger was broken on the architect i1000sr, serial (b)(6).Service replaced the fitting kit, trigger_pre-trigger (rohs) thus resolving the issue.The service history of the (b)(6) found no additional falsely false elevated stat high sensitive troponin-i results were reported post the current event was identified.A review of trending data associated with the fitting kit, trigger_pre-trigger (rohs) did not identify an increase in complaint activity.A review of complaint and trending data for the architect i1000sr, serial (b)(6) did not identify any similar issues for with regards to the current issue.A device history record did not identify any nonconformances or deviations associated with the complaint issue.Labeling was reviewed and adequately addresses the current issue.Based on the investigation, no systemic issue or product deficiency of the architect i1000sr serial (b)(6) or the fitting kit, trigger_pre-trigger (rohs) were identified.
Event or Problem Description
The customer reported a false positive architect stat high sensitive troponin-i result generated on the architect i1000sr instrument.The following data was provided (customer¿s normal reference range: 0.00-0.07 ng/ml): sid (b)(6): initial result = 0.108 ng/ml.Repeat on same analyzer = 0.068 ng/ml.Repeat on another analyzer (sn (b)(6)) = 0.018 / 0.016 ng/ml.The positive troponin-i result was not reported to the patient¿s chart.The troponin-i test was an add on and the sample was sitting for 3 hours prior to testing.The customer inspected the instrument and discovered the pre-trigger and trigger solution volume was below 20%.The customer while changing the pre-trigger and trigger solution bottles, the opaque connector tubing broke off.There was no impact to patient management reported.

• Brand Name: ARCHITECT I1000SR PROCESSING MODULE (INTEGRATED)
• 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: 21885278
• Report Number: 3016438761-2025-00242
• Device Sequence Number: 8190130
• Product Code: JJE
• UDI-Device Identifier: 00380740001544
• UDI-Public: (01)00380740001544
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2025

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: 01L86-40
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 04/10/2025; 05/07/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 04/22/2025; 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2012
• 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 TROPONIN HS RGT 100, 02R98-25, 93900UN24; ARC TROPONIN HS RGT 100, 02R98-25, 93900UN24; FITTING KIT, TRIGGER_PRE-TRIGGER (ROHS), 7-77664-0
• Patient Sex: Unknown