MAUDE Adverse Event Report: Abbott Ireland Diagnostics Division ARCHITECT STAT Myoglobin; MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL

Catalog Number	02K43-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed architect myoglobin results for four samples.The following data was provided: sample 1 initial architect myoglobin result 12 ng/ml, retest 40 ng/ml, sample 2 initial architect myoglobin result 9.2 ng/ml, retest 31.4 ng/ml, sample 3 initial architect myoglobin result 91 ng/ml, retest 412.1 ng/ml, sample 4 initial architect myoglobin result 70 ng/ml, retest 336.6 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.

• Brand Name: ARCHITECT STAT Myoglobin
• Common Device Name: MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
• Manufacturer (Section D): Abbott Ireland Diagnostics Division; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): Abbott Ireland Diagnostics Division; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; +49()6122582960
• MDR Report Key: 50803312
• Report Number: 3008344661-2026-00143
• Device Sequence Number: 16089199
• Product Code: DDR
• UDI-Device Identifier: 00380740003296
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 02K43-20
• Device Lot Number: 42532UN25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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,(b)(6)
• Patient Sex: Unknown