MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT TACROLIMUS REAGENT KIT; ENZYME IMMUNOASSAY, TRACROLIMUS

Model Number	1L77-25
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer questioned architect tacrolimus results for one patient.The patient is a 15 year-old female, sid (b)(6) result of 2.98 pg/ml (reference range: 5-20) was questioned by the physician as skewed low.The patient was originally tested at another laboratory using a different platform, with results all within the reference range.No impact to patient management was reported.
Additional Manufacturer Narrative
The evaluation of complaint data for the product and likely cause architect tacrolimus reagent lot 33444fp00 identified normal complaint activity and there are no trends for the product related to patient results.No customer returns were available for evaluation.Inhouse testing determined that the accuracy performance is not negatively impacted.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.The performance of the likely cause lot was investigated by completing a review for non-conformances, potential non-conformances and deviations related to the likely cause lot.This review did not identify any non-conformances, potential non-conformances, or deviations.A review of labeling concluded that the issue is sufficiently addressed.Based on our investigation no systemic issue or product deficiency of the architect tacrolimus reagent lot 33444fp00 was identified.

• Brand Name: ARCHITECT TACROLIMUS REAGENT KIT
• Common Device Name: ENZYME IMMUNOASSAY, TRACROLIMUS
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14288706
• Report Number: 1415939-2022-00034
• Device Sequence Number: 20185348
• Product Code: MLM
• UDI-Device Identifier: 00380740001377
• UDI-Public: 00380740001377
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K070820
• 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): 06/09/2022

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: 02/07/2023
• Device Model Number: 1L77-25
• Device Catalogue Number: 01L77-25
• Device Lot Number: 33444FP00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• 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 I2000SR INST, 03M74-02, ISR64078; ARC I2000SR INST, 03M74-02, ISR64078
• Patient Age: 15 YR
• Patient Sex: Female