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

Catalog Number 07P57-20

Device Problem High Test Results (2457)

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

Event Date 11/21/2023

Event Type  malfunction  

Event Description

The customer stated that falsely elevated alinity c calcium results of 3.4 and 4.2 mmol/l were generated for a patient sample (sid (b)(6)) that retested at 2.00 and 1.99 mmol/l after sample re-centrifugation.The customer's normal range is 2.2 mmol/l to 2.6 mmol/l.The customer does not believe the issue was related to sample integrity.No impact to patient management was reported.

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.

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.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Device history record review on lot number 26375un23 did not identify any non-conformances or deviations with the likely cause lot.Quality controls were in range at the time of the discrepant result, indicating the assay is performing as expected.To further investigate the customer¿s issue, the historical performance of reagent lot 26375un23 was evaluated using world-wide data gathered from customers.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 26375un23 is within the established control limits, suggesting that the performance is acceptable.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 26375un23, was identified.

Event Description

The customer stated that falsely elevated alinity c calcium results of 3.4 and 4.2 mmol/l were generated for a patient sample (sid (b)(6) that retested at 2.00 and 1.99 mmol/l after sample re-centrifugation.The customer's normal range is 2.2 mmol/l to 2.6 mmol/l.The customer does not believe the issue was related to sample integrity.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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18307404
• MDR Text Key: 330939804
• Report Number: 3002809144-2023-00490
• Device Sequence Number: 1
• Product Code: CJY
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2024
• Device Catalogue Number: 07P57-20
• Device Lot Number: 26375UN23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• 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).