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 04/15/2023

Event Type  malfunction  

Event Description

The customer observed falsely elevated alinity c calcium result generated for a patient, which was not consistent with the patient¿s historical results.The sample was repeated on two other analyzers, and the results were lower.It was noted, that this sample had generated error code 3430 (unable to process test.Sample aspiration error) on several other assays.The following data was provided: normal range is 90 to 110 mg/l.(b)(6) 2023, sid (b)(6) initial result = 153.08 mg/l; repeat results = 92, 89 mg/l (different alinity analyzers).Patient¿s historical results = 88, 89 mg/l.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely elevated alinity c calcium result, 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.Abbott customer support reviewed instrument logs and found several assays were rerun on the same sample; due to generation of error code 3430 (unable to perform the test.Sample aspiration error), and error code 3022 (unable to perform the test because of a sample aspiration error).Sample integrity was suspected as the likely cause of the issue.No issue is reported for the quality control results.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.

• 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: 16845378
• MDR Text Key: 314310775
• Report Number: 3002809144-2023-00205
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740132613
• UDI-Public: 00380740132613
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 05/01/2023

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: 04/17/2023
• Initial Date FDA Received: 05/01/2023
• 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, AC04714