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

Catalog Number	02K43-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated architect stat myoglobin result for a male patient, who had no myocardial infarction symptoms.The following data was provided (customer¿s normal range is <154.9 ng/ml): initial result was >1200, 1:10 dilution result was 4192 ng/ml.The sample was tested with a micropoint test, and the result was 0.15 ng/ml, reference range is <0.3 ng/ml.The sample was also tested with a nanjing getein biotech poct instrument, and the result was >600 ng/ml.The sample was sent out for testing using a roche assay and the result was 1751.0 ng/ml, reference range is 28-72 ng/ml.The sample was also tested with a beckman assay and the result was 2187.9 ng/ml.It was noted that based on the elevated results, the patient received an electrocardiogram and infusion therapy.The patient had no symptoms and had since been discharged.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.Section e1 - phone complete entry = (b)(6).
Additional Manufacturer Narrative
The complaint investigation for a falsely elevated architect stat myoglobin result 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 a retained kit of the complaint lot number.Trending review determined no related trend for the issue for the product.Return testing was not completed, as returns were not available.Accuracy testing was performed using an in-house retained kit of lot 56175un22, stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of architect stat myoglobin reagent, lot number 56175un22, was identified.Section g1 contact information was updated to reflect the current contact (b)(6).
Event or Problem Description
The customer observed falsely elevated architect stat myoglobin result for a male patient, who had no myocardial infarction symptoms.The following data was provided (customer¿s normal range is <154.9 ng/ml): initial result was >1200, 1:10 dilution result was 4192 ng/ml.The sample was tested with a micropoint test, and the result was 0.15 ng/ml, reference range is <0.3 ng/ml.The sample was also tested with a nanjing getein biotech poct instrument, and the result was >600 ng/ml.The sample was sent out for testing using a roche assay and the result was 1751.0 ng/ml, reference range is 28-72 ng/ml.The sample was also tested with a beckman assay and the result was 2187.9 ng/ml.It was noted that based on the elevated results, the patient received an electrocardiogram and infusion therapy.The patient had no symptoms and had since been discharged.

• 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
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17864799
• Report Number: 1415939-2023-00054
• Device Sequence Number: 20367300
• Product Code: DDR
• UDI-Device Identifier: 00380740003302
• UDI-Public: 00380740003302
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042924
• 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): 11/01/2023

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: 10/31/2023
• Device Catalogue Number: 02K43-25
• Device Lot Number: 56175UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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 I1000SR MOD, 01L86-01, (B)(6); ARC I1000SR MOD, 01L86-01, (B)(6)
• Patient Sex: Male