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	06/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed false reactive architect havab-igg result generated on the architect i2000sr processing module for one patient.The sample was repeated and nonreactive results were obtained.The customer stated all the retest results were from the same sample.The following data was provided (<1.00 s/co is nonreactive, = 1.00 s/co is reactive): on (b)(6) 2024 sid (b)(6) (b)(6) result = 1.08 s/co (reactive).(b)(6) 2024 sid (b)(6) (b)(6) result = 0.95 s/co (non-reactive).(b)(6) 2024 sid (b)(6) (b)(6) result = 0.12 s/co (non-reactive).(b)(6) 2024 sid (b)(6) (b)(6) result = 0.12 s/co (non-reactive).(b)(6) 2024 sid (b)(6) (b)(6) result = 0.17 s/co (non-reactive).There was no impact to patient management reported.
Additional Manufacturer Narrative
Section a1 - patient identifier: all the sids were from one patient.Sids = (b)(6).This issue was previously reported under mdr number 3002809144-2024-00196 under a different suspect device.The field service representative (fsr) inspected the instrument, and performed troubleshooting but was unable to determine a single definitive cause of the discrepant result.The architect i2000sr processing module was considered the likely cause.An instrument service history review revealed no additional service tickets associated with false reactive architect havab-igg results reported for (b)(6).A review of tracking and trending of the immunoassay systems did not identify any similar issues related to the architect system or discrepant results as described in this complaint.The device history record was reviewed, and no non-conformances or deviations was identified.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the architect i2000sr processing module serial number (b)(6) was identified.

• 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: 19809718
• Report Number: 3016438761-2024-00422
• Device Sequence Number: 20927799
• Product Code: JJE
• UDI-Device Identifier: 00380740023386
• UDI-Public: (01)00380740023386
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 07/23/2024

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: 07/10/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2016
• 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 HAVAB IGG RGT 400T, 06C29-22, (B)(6)
• Patient Sex: Unknown