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

Catalog Number	07P57-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3002809144-2023-00490
• Device Sequence Number: 20512759
• Product Code: CJY
• UDI-Device Identifier: 00380740132613
• UDI-Public: 00380740132613
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K062855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY C PROCESSING MODU, 03R67-01, (B)(6).; ALNTY C PROCESSING MODU, 03R67-01, (B)(6).
• Patient Sex: Unknown