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

Catalog Number 07P57-30

Device Problem High Test Results (2457)

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

Event Date 07/12/2023

Event Type  malfunction  

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 Description

The customer observed falsely elevated calcium results generated on the alinity c processing module for one sample.(customer provided calcium reference range 2.10 ¿ 2.60 mmol/l) sid (b)(6) calcium, initial run = 3.54 mmol/l, 2nd run = 5.36 mmol/l, 2.61 mmol/l, 2.55 mmol/l (result that was reported).No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false falsely elevated alinity c calcium results 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.Trending review did not identify any trends for the issue for the product.Device history record review on lot 53550un22 did not show any potential non-conformances, deviations, or non-conformances associated with the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation, no systemic issue or deficiency with the alinity c calcium assay for lot 53550un22 was identified.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely elevated calcium results generated on the alinity c processing module for one sample.(customer provided calcium reference range 2.10 ¿ 2.60 mmol/l) sid (b)(6) calcium, initial run = 3.54 mmol/l, 2nd run = 5.36 mmol/l, 2.61 mmol/l, 2.55 mmol/l (result that was reported).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: 17423720
• MDR Text Key: 320036244
• Report Number: 3002809144-2023-00333
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740135409
• UDI-Public: 00380740135409
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 07P57-30
• Device Lot Number: 53550UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1