MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CALCIUM REAGENT KIT; AZO DYE, CALCIUM

Model Number	07P5720
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final 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 observed a falsely elevated calcium result generated on the alinity c processing module for a patient sample.The following data was provided (reference range 8.4 to 10.2 mg/dl): sample id (b)(6) initial result = 14.31 mg/dl, repeat = 9.49 mg/dl no impact to patient management was reported.
Additional Manufacturer Narrative
Update: section d4 - expiration date updated from blank to 9/23/2023, and h4 - device mfg date updated from blank to 8/8/2022.The complaint investigation for falsely elevated alinity c calcium results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.Return testing was not completed as returns were not available.Troubleshooting of the alinity c processing module, serial number ac05019, was performed which included washing the cuvettes with detergent a.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Ticket search by lot indicates the reagent lot is performing as expected for this product.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 66942un22 and complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Based on this investigation, no systemic issue or deficiency was identified for the alinity c calcium reagent lot 66942un22.
Event or Problem Description
The customer observed a falsely elevated calcium result generated on the alinity c processing module for a patient sample.The following data was provided (reference range 8.4 to 10.2 mg/dl): sample id (b)(6) initial result = 14.31 mg/dl, repeat = 9.49 mg/dl no impact to patient management was reported.

• Brand Name: ALINITY C CALCIUM REAGENT KIT
• Common Device Name: AZO DYE, CALCIUM
• 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: 16853594
• Report Number: 3002809144-2023-00207
• Device Sequence Number: 7555725
• Product Code: CJY
• UDI-Device Identifier: 00380740132613
• UDI-Public: 00380740132613
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K062855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2023

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 Expiration Date: 09/23/2023
• Device Model Number: 07P5720
• Device Catalogue Number: 07P57-20
• Device Lot Number: 66942UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• 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, AC05019; ALNTY C PROCESSING MODU, 03R67-01, AC05019
• Patient Sex: Unknown