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

Model Number	01L8684
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Completed information for patient identification: sids: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a false positive architect stat troponin-i result generated on the architect i1000sr processing module for one patient.The customer reported the patient was admitted to the hospital for close monitoring.The following results were provided: (customer provided normal reference range 0.0-0.03 ng/ml), on (b)(6) 2023, sid: (b)(6), (sn: (b)(4) initial sample result = 0.084 ng/ml, on (b)(6) 2023, sid: (b)(6), (sn: (b)(4) redraw result = 0 ng/ml, on (b)(6) 2023, sid: (b)(6), (sn: (b)(4) second redraw result = 0 ng/ml, on (b)(6) 2023, sid: (b)(6), (sn: (b)(4) 3350 unable to process test, aspiration error, on (b)(6) 2023, sid: (b)(6), (sn: (b)(4) 0.002 ng/ml, on (b)(6) 2023, sid: (b)(6), (sn: (b)(4) 0 ng/ml, on (b)(6) 2023, sid: (b)(6), (sn: (b)(4) 0.008 ng/ml, on (b)(6) 2023, sid: (b)(6), (sn:(b)(4) 0 ng/ml, on (b)(6) 2023, sid: (b)(6), (sn: (b)(4) 0 ng/ml, on (b)(6) 2023, sid: (b)(6), (sn:(b)(4) 0.014 ng/ml, on (b)(6) 2023, sid: (b)(6), (sn: (b)(4) 0 ng/ml, on (b)(6) 2023, sid: (b)(6), (sn:(b)(4) 0 ng/ml.No impact to patient management was reported.
Event or Problem Description
The customer observed false positive architect stat troponin-i results generated on the architect i1000sr processing module for one patient.The customer reported the patient was admitted to the hospital for close monitoring.The following results were provided: (customer provided normal reference range 0.0-0.03 ng/ml).On (b)(6) 2023 sid (b)(6) (sn (b)(6)) initial sample result = 0.084 ng/ml.On (b)(6) 2023 sid (b)(6) (sn (b)(6)) redraw result = 0 ng/ml.On (b)(6) 2023 sid (b)(6) (sn (b)(6)) second redraw result = 0 ng/ml.On (b)(6) 2023 sid (b)(6) (sn (b)(6)) 3350 unable to process test, aspiration error.On (b)(6) 2023 sid (b)(6) (sn (b)(6)) 0.002 ng/ml.On (b)(6) 2023 sid (b)(6) (sn (b)(6)) 0 ng/ml.On (b)(6) 2023 sid (b)(6) (sn (b)(6)) 0.008 ng/ml.On (b)(6) 2023 sid (b)(6) (sn (b)(6)) 0 ng/ml.On (b)(6) 2023 sid (b)(6) (sn (b)(6)) 0 ng/ml.On (b)(6) 2023 sid 1732 (sn (b)(6)) 0.014 ng/ml.On (b)(6) 2023 sid 1840 (sn (b)(6)) 0 ng/ml.On (b)(6) 2023 sid (b)(6) (sn (b)(6)) 0 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
It was discovered on august 30, 2023 that the initial and supplemental emdrs for this issue were submitted under the correct suspect medical device but incorrect manufacturer name, city and state.Mdr number 3016438761-2023-00466 has been submitted for the correct manufacturing site and all further information will be documented under that mdr.
Additional Manufacturer Narrative
A review of the instrument logs found the following error codes were generated around the time the sample in question was processed: 0302 unable to process test, hardware failure or the user pressed stop.3350 unable to process test, aspiration error for (pipetter) at (sh sample).3368 aspiration error on liquid level sense board (0), shape conform score.The customer calibrated the sample probe as instructed/suggested to resolve the issue.The sample arc, probe was deemed the likely cause for the false elevated troponin results.Labeling was reviewed and provides adequate information regarding the troubleshooting of erratic/discrepant results.The instrument service history review revealed no additional service tickets associated with discrepant/erratic results.A review of historical data found no non-conformances related to the current complaint.A review of tracking and trending for the arc, probe did not identify any trends.A review of the scorecard identified no similar issues related to the architect i1000sr or likely cause parts as described.Based on the investigation, no systemic issue or deficiency for the architect i1000sr processing module, sn (b)(6) or arc, probe was identified.All available patient information was included.Additional patient details are not available.

• Brand Name: ARCHITECT I1000SR
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16583288
• Report Number: 1628664-2023-00002
• Device Sequence Number: 11948882
• Product Code: JJE
• UDI-Device Identifier: 00380740116941
• UDI-Public: 00380740116941
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/01/2023

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 Model Number: 01L8684
• Device Catalogue Number: 01L86-84
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 04/04/2023; 08/30/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 04/06/2023; 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• 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 I1SR REFURB-MEXICO, 01L86-84,(B)(6); ARC I1SR REFURB-MEXICO, 01L86-84,(B)(6); ARC I1SR REFURB-MEXICO, 01L86-84,(B)(6); ARC TROP RGT, 02K41-27, 55235UN22; ARC TROP RGT, 02K41-27, 55235UN22; ARC TROP RGT, 02K41-27, 55235UN22
• Patient Sex: Unknown