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

Catalog Number	01L86-84
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated architect stat troponin-i results on two patients.The results provided were: on (b)(6) 2021 sid (b)(6) initial=128.49 ng/l /repeated=15.854 ng/l /repeated on another analyzer=11.055 ng/l.Sid = (b)(6) initial=561.252 ng/l /repeated=0.000 ng/l /repeated on another analyzer=0.00 ng/l.Laboratory normal reference range = 55 - 74 ng/l there was no reported impact to patient management.
Additional Manufacturer Narrative
This issue was previously reported under mdr number 1628664-2021-00013 under the same suspect medical device but an incorrect manufacturer name, city and state.Complete information for section a patient information, 1.Patient identifier = sid= (b)(6).The field service representative (fsr) inspected the analyzer replaced the probe next r (03r85-01), which resolved the issue.A review of the architect i1000sr processing module, serial number (b)(6) service history found no contributing factors on or around the date of the complaint.A review of tracking and trending of the architect i1sr processing module or the probe next r (03r85-01), did not identify any trends associated with the complaint issue.A review of historical data revealed no trends, systemic issues, or related nonconformances.A review of the (b)(6) service history was performed and no additional erratic results pre- or post the current complaint were identified.The architect system operations manual addresses operational precautions and limitations and troubleshooting of the fluidics subsystem.The operations manual also addresses troubleshooting of elevated concentration and erratic sample results.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for either the architect i1000sr processing module, serial number (b)(6) , or the probe next r (03r85-01).

• Brand Name: ARCHITECT I1000SR
• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17671907
• Report Number: 3016438761-2023-00467
• Device Sequence Number: 20461203
• Product Code: JJE
• UDI-Device Identifier: 00380740116941
• UDI-Public: 00380740116941
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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 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: 08/30/2023
• Initial Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• 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
• Patient Sex: Unknown