MAUDE Adverse Event Report: Abbott Ireland Diagnostics Division Alinity i STAT Myoglobin Reagent Kit; MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL

Catalog Number	04V37-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2026
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.Section a patient information: refer to section b5 for complete patient information.
Event or Problem Description
The customer observed falsely decreased alinity i myoglobin results generated on a 59yrs old male patient.The results provided were: sid (b)(6) new reagent=131.7 ng/ml /previous reagent=163.8 ng/ml.Laboratory reference range for myoglobulin= < 140 ng/ml there was no reported impact to patient management.

• Brand Name: Alinity i STAT Myoglobin Reagent Kit
• 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: 25473336
• Report Number: 3008344661-2026-00089
• Device Sequence Number: 10426520
• Product Code: DDR
• UDI-Device Identifier: 00380740174903
• UDI-Public: (01)00380740174903(17)270803(10)83252FZ00
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 08/10/2026

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: 04V37-20
• Device Lot Number: 83252FZ00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2026
• Supplement Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I STAT MYO CAL, 04V37-01, 65742UN26.
• Patient Age: 59 YR
• Patient Sex: Male