MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT IDIGOXIN

Model Number	01P3227
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient id for one patient was sid (b)(6), other sids are unknown.All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported false decreased digoxin results for multiple patients, when processing on the architect i2000sr.The customer stated samples that generated a result of <0.4 were sent to another hospital to be tested with a different instrument.Additionally, the customer reported that one of the patients (sid unknown) was treated with an excess digoxin dose as a result of the false decreased digoxin result.Result for this patient was <0.4 on the architect and at another hospital the ortho instrument generated a result of 2.15.The customer stated there was no adverse impact to the patient as a result of the digoxin treatment.The following data was provided, sids are unknown (first value corresponds to the i2000sr result and second value is the result generated using vitros method): 0.5 and 1.26.0.7 and 1.46.<0.4 and 0.6.<0.4 and 0.7.1.1 and 1.38.Sid (b)(6): <0.4 and 3.59.Sid (b)(6): <0.4 and 2.68.No additional impact to patient management was reported.
Additional Manufacturer Narrative
Upon retrospective review, a typographical error was discovered.In the report it stated an increase in complaint activity related to falsely elevated results.Corrected data should be an increase in complaint activity related to falsely decreased results.
Additional Manufacturer Narrative
An investigation was performed for the customer issue and included a review of the complaint text, a search for similar complaints, a review of trending data, a review of the historical performance of lot 02118i000, a review of device history, and a review of product labeling.Review of the ticket trending and lot search did not identify an increase in complaint activity related to falsely elevated results.The reagent lot 02118i000 expired on 02/29/2020, therefore no accuracy testing was performed.A device history record review was performed on reagent lot, which did not identify any issues.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.
Additional Manufacturer Narrative
On 25feb2020, the lot number was updated from unknown to lot 02118i000, reflected in section d4.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

• Brand Name: ARCHITECT IDIGOXIN
• Common Device Name: IDIGOXIN
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 9728838
• Report Number: 1415939-2020-00016
• Device Sequence Number: 2871578
• Product Code: KXT
• UDI-Device Identifier: 00380740155988
• UDI-Public: 00380740155988
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/20/2020

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 Expiration Date: 02/29/2020
• Device Model Number: 01P3227
• Device Catalogue Number: 01P32-27
• Device Lot Number: 02118I000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 02/25/2020; 04/15/2020; 04/20/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/25/2020; 04/16/2020; 04/20/2020
• 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: ARCHITECT I1000SR ANALYZER; ARCHITECT I1000SR ANALYZER; ARCHITECT I1000SR ANALYZER; LN 01L86-01 SN (B)(6) ; LN 01L86-01 SN (B)(6) ; LN 01L86-01 SN (B)(6)