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

Model Number 07P5720

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/24/2023

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 314389724
• Report Number: 3002809144-2023-00207
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740132613
• UDI-Public: 00380740132613
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K062855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 08/03/2023
• Supplement Dates FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC05019; ALNTY C PROCESSING MODU, 03R67-01, AC05019