MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C MICROALBUMIN; TURBIDIMETRIC METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)

Catalog Number	08P04-24
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the urine microalbumin assay was configured incorrectly on the alinity c processing module by abbott resulting in five patient samples 10x higher than previous history.Example results provided: sid (b)(6): raw result 0.769; result reported 7.6912 mg/dl sid (b)(6): raw result: 17.618; result reported:176.1848 mg/dl the uom should be configured on the analyzer to be ug/ml or mg/l, not mg/dl.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.All available patient information was included.Additional patient details are not available.Section a1 patient identifier sids: (b)(6).
Additional Manufacturer Narrative
A review of complaints for the alinity c microalbumin assay determined that there are no trends for the product related to patient results.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.Return testing was not completed as returns were not available.A review of the product labeling concluded that the issue is sufficiently addressed.File sample analysis was not performed as the issue was found to be the urine microalbumin assay was configured incorrectly on the alinity c processing module the unit should be configured on the analyzer to be ug/ml or mg/l, not mg/dl.The patient samples results were recalculated after correcting the assay parameters and results were as expected with the units of measurement.Based on the investigation no systemic issue or product deficiency was identified.
Event or Problem Description
The customer reported the urine microalbumin assay was configured incorrectly on the alinity c processing module by abbott resulting in five patient samples 10x higher than previous history.Example results provided: sid (b)(6): raw result 0.769; result reported 7.6912 mg/dl.Sid (b)(6): raw result: 17.618; result reported:176.1848 mg/dl.The uom should be configured on the analyzer to be ug/ml or mg/l, not mg/dl.No impact to patient management was reported.

• Brand Name: ALINITY C MICROALBUMIN
• Common Device Name: TURBIDIMETRIC METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 21871297
• Report Number: 3002809144-2025-00136
• Device Sequence Number: 8768888
• Product Code: JIQ
• UDI-Device Identifier: 00380740190781
• UDI-Public: (01)00380740190781(17)260411(10)66362UD00
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: 04/11/2026
• Device Catalogue Number: 08P04-24
• Device Lot Number: 66362UD00
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2024
• 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: ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Sex: Unknown