MAUDE Adverse Event Report: ABBOTT GERMANY ALINITY C CREATININE

Catalog Number	07P99-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2019
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a falsely increased creatinine result generated on the alinity c analyzer on one patient.Results provided: 10.86 / 0.86 mg/dl.Creatinine historically = 0.81 / 0.83 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
A review of complaints determined that there are no trends for the product for the complaint issue.The lot search for reagent lot 99551un18 also did not identify an increase in complaint activity.Return testing was not completed as returns were not available.A review of the manufacturing documentation for the likely cause did not identify any issues associated with the customers observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the information in this investigation, the reagent lot 99551un18 expired on may 05, 2019 and the customer processed using this lot in november 2019.Reliability of assay results cannot be guaranteed if there are any deviations from the package insert instruction.No product deficiency was identified for the alinity c creatinine assay, lot 99551un18.

• Brand Name: ALINITY C CREATININE
• Common Device Name: CREATININE
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9404450
• Report Number: 3002809144-2019-01001
• Device Sequence Number: 2579590
• Product Code: CGX
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (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): 12/19/2019

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: 05/05/2019
• Device Catalogue Number: 07P99-20
• Device Lot Number: 99551UN18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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: ALINITY C PROCESSING MODULE LIST 03R67-01; ALINITY C PROCESSING MODULE LIST 03R67-01; SERIAL (B)(4); SERIAL (B)(4)