MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT STAT MYOGLOBIN REAGENT KIT; MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL

Model Number	2K43-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier = sid= (b)(6).(b)(4).Was this device serviced by a third party?: no.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated architect stat myoglobin results on one patient.The results provided were: sid (b)(6) initial=1003.7 ng/ml / repeated due to questioned by physician =51 ng/ml there was no reported impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and in-house testing of architect stat myoglobin reagent lot 57557un20.Trending review determined no adverse trend for the issue for the product.Return testing was not completed as returns were not available.Trending review determined no adverse trend for the issue for the product.Accuracy testing was performed using a retained kit of lot 57557un20 with panels, which mimic patient samples, and all specifications were met indicating that the lot is performing acceptably.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.There was no issue with reagent performance identified.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect stat myoglobin reagent lot 57557un20.

• Brand Name: ARCHITECT STAT MYOGLOBIN REAGENT KIT
• Common Device Name: MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• MDR Report Key: 11801795
• Report Number: 1415939-2021-00022
• Device Sequence Number: 11613431
• Product Code: DDR
• UDI-Device Identifier: 00380740003296
• UDI-Public: 00380740003296
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup,Followup
• Report Date (Section B): 07/27/2021

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: 10/31/2021
• Device Model Number: 2K43-20
• Device Catalogue Number: 02K43-20
• Device Lot Number: 57557UN20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 06/21/2021; 07/23/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 07/01/2021; 07/27/2021
• 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 I1000SR MOD, 01L86-01, (B)(6).