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

Catalog Number	03M74-84
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 patient identifier: complete sample id was (b)(6).All available patient information was included.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported false reactive architect total b-hcg and provided the following data for 1 patient (reference: = 5.00 miu/ml is negative, = 25.00 miu/ml is positive, > 5.00 miu/ml and < 25.00 miu/ml are considered grayzone - no interpretation will be reported for these results): on 8 nov sample id (b)(6) result was 967.34 miu/ml (positive) and when repeated on 16 nov the result was <1.2 miu/ml (negative).On 16 nov the sample was tested on another platform and generated a result of <5miu/ml.There was no reported impact to patient management.
Additional Manufacturer Narrative
The architect i2000sr, serial # (b)(6) inspected and found serum/crystallization/particles in the reaction vessel 1 (rv1) and determined the diverter, load and unload - moulded base (rohs) required cleaning.It was determined the issue was resolved by performing as needed maintenance.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The instrument service history review revealed no additional issues related to false positive results.A review of tracking and trending did not identify a trend for the diverter, load and unload - moulded base (rohs) or architect i2000sr as with regards to the customer reported event.A review of the manufacturing documentation did not identify any non-conformances or potential non-conformances related to the diverter, load and unload - moulded base (rohs).Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified for the diverter, load and unload - moulded base (rohs) or architect i2000sr, serial # (b)(6).
Event or Problem Description
The customer reported false reactive architect total b-hcg and provided the following data for 1 patient (reference: = 5.00 miu/ml is negative, = 25.00 miu/ml is positive, > 5.00 miu/ml and < 25.00 miu/ml are considered grayzone - no interpretation will be reported for these results): on 8 nov sample id (b)(6) result was 967.34 miu/ml (positive) and when repeated on 16 nov the result was <1.2 miu/ml (negative).On 16 nov the sample was tested on another platform and generated a result of <5miu/ml.There was no reported impact to patient management.

• 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: 18222602
• Report Number: 3016438761-2023-00625
• Device Sequence Number: 14880324
• Product Code: JJE
• UDI-Device Identifier: 00380740107222
• UDI-Public: 00380740107222
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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: 03M74-84
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2006
• 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 TOT BHCG RGT 500 TE, 07K78-35, 45625UD00; ARC TOT BHCG RGT 500 TE, 07K78-35, 45625UD00
• Patient Sex: Unknown