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

Model Number	08P0420
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported that the microalbumin college of american pathologists (cap) survey failed on the alinity c processing module (b)(6), as all results on the 5 microalbumin cap challenge were falsely depressed and off by 1 decimal place.It was determined that when the instrument was first installed, mg/l was used for alinity c microalbumin and at some point in time the unit of measure configuration was changed to mg/dl.The customer communicated that abbott assisted the customer with this configuration step.Upon further review, the actual units were changed for the assay, but not for the calibrator.The configuration values were all updated to be synchronous with the mg/dl unit of measure from the mg/l unit of measure.A data pull of all microalbumin samples reported since the assay went live in january 2023 was completed with a total of 591 patient samples.Initial review of the data does not include data from january to (b)(6) 2023 nor does it include objective values.Customer normal range ualb is 0.5-29 mg/dl.The corrected results from the reviewed data is as follows.In reviewing the data: abnormal to normal = 110 specimens, abnormal to abnormal = 30 specimens, less than 5 = 68 specimens, greater than 200 = 5 specimens.There has been no known reported impact to patient management.
Event or Problem Description
The customer reported that the microalbumin college of american pathologists (cap) survey failed on the alinity c processing module sn: (b)(6) as all results on the 5 microalbumin cap challenge were falsely depressed and off by 1 decimal place.It was determined that when the instrument was first installed, mg/l was used for alinity c microalbumin and at some point in time the unit of measure configuration was changed to mg/dl.The customer communicated that abbott assisted the customer with this configuration step.Upon further review, the actual units were changed for the assay, but not for the calibrator.The configuration values were all updated to be synchronous with the mg/dl unit of measure from the mg/l unit of measure.A data pull of all microalbumin samples reported since the assay went live in january 2023 was completed with a total of 591 patient samples.Initial review of the data does not include data from january to february 20, 2023 nor does it include objective values.Customer normal range ualb is 0.5-29 mg/dl.The corrected results from the reviewed data is as follows in reviewing the data: ¿ abnormal to normal = 110 specimens ¿ abnormal to abnormal = 30 specimens ¿ less than 5 = 68 specimens ¿ greater than 200 = 5 specimens.There has been no known reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation regarding alinity c microalbumin results that were off by 1 decimal spot included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.Ticket and trending review for the alinity c microalbumin reagent did not identify any related trends.Device history record review did not identify any deviations or non-conformances.A labeling review determined product labeling provides adequate information regarding the customer issue.After the field service engineer assisted the customer to change all the applicable alinity c microalbumin unit of measure to mg/dl from mg/l, no further issues have been noted.Based on the investigation, no systemic issue or deficiency with the alinity c microalbumin reagent was identified.

• Brand Name: ALINITY C MICROALBUMIN REAGENT KIT
• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16863273
• Report Number: 3002809144-2023-00219
• Device Sequence Number: 14911043
• Product Code: JIQ
• UDI-Device Identifier: 00380740135201
• UDI-Public: 00380740135201
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/11/2023

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 Model Number: 08P0420
• Device Catalogue Number: 08P04-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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, AC05143; ALNTY C PROCESSING MODU, 03R67-01, AC05143.
• Patient Sex: Unknown