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	07/03/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer reported falsely elevated calcium results generated on the alinity c processing module on a patient.Results provided: (b)(6) 2024 sid (b)(6) = 5.54 / 4.59 / 2.14 / 2.09 / 2.10 / 2.30 / 2.08 mmol/l (normal range: 2.2-2.6 mmol/l).No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for a falsely elevated alinity c calcium result included a review of data and information provided by the customer, labeling review, search for similar complaints, ticket trending 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.Labeling was reviewed and sufficiently addresses the customer's issue.To further investigate the customer¿s issue, the historical performance of alinity c calcium reagent lot 07559un23 was evaluated using world-wide data.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 07559un23 is within the established limits.Therefore, no unusual reagent lot performance was identified device history record review did not identify any nonconformances or deviations associated with the likely lot number 07559un23 and complaint issue.Based on our investigation, no systemic issue or deficiency with the alinity c calcium reagent for lot 07559un23 was identified.
Event or Problem Description
The customer reported falsely elevated calcium results generated on the alinity c processing module on a patient.Results provided: (b)(6) 2024 sid (b)(6) = 5.54 / 4.59 / 2.14 / 2.09 / 2.10 / 2.30 / 2.08 mmol/l (normal range: 2.2-2.6 mmol/l).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: 19849379
• Report Number: 3002809144-2024-00219
• Device Sequence Number: 6796223
• Product Code: CJY
• UDI-Device Identifier: 00380740132613
• UDI-Public: (01)00380740132613(17)250228(10)07559UN23
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/26/2024

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: 02/28/2025
• Device Catalogue Number: 07P57-20
• Device Lot Number: 07559UN23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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