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

Model Number 07P5730

Device Problem High Test Results (2457)

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

Event Date 02/14/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.Initial reporter phone complete entry = (b)(6).

Event Description

The customer observed a falsely elevated alinity c calcium result for one patient.The following data was provided (customer¿s normal range is 2.1-2.55 mmol/l): sample id (b)(6) initial result 5.62, repeat, on another analyzer, was 2.25 mmol/l.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for falsely elevated alinity c calcium results included a review of data 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 determined no related trend for the issue for the product.Device history record review did not show any potential non-conformances or deviations.Quality controls were in range at the time of the discrepant result, indicating the assay is performing as expected.Labeling was reviewed and found to adequately address the issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency for alinity c calcium reagent lot number 41869un22, was identified.

Event Description

The customer observed a falsely elevated alinity c calcium result for one patient.The following data was provided (customer¿s normal range is 2.1-2.55 mmol/l): sample id (b)(6) initial result 5.62, repeat, on another analyzer, was 2.25 mmol/l.There was no impact to patient management 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: 16432488
• MDR Text Key: 310264716
• Report Number: 3002809144-2023-00094
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740135409
• UDI-Public: 00380740135409
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/24/2023

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: 08/16/2023
• Device Model Number: 07P5730
• Device Catalogue Number: 07P57-30
• Device Lot Number: 41869UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2022
• 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, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)