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

Catalog Number	07P57-30
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete entry section a1 - patient identifier: (b)(6).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 observed falsely elevated alinity c calcium for one patient.The following results were provided (reference range 2.10 to 2.55 mmol/l): on (b)(6) 2024, sid (b)(6), initial result= 4.072 mmol/l; repeat result= 2.54 mmol/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, field data review and labeling review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.The search for similar complaints for lot 17995un23 did not identify an increase in complaint activity for the current issue.A ticket trending review did not identify any trends related to this issue.The device history record review did not identify any nonconformances related to lot number 17995un23 and complaint issue.The field data review of lot 17995un23 indicates the patient median is within the established limits.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity c calcium reagent lot 17995un23 was identified.
Event or Problem Description
The customer observed falsely elevated alinity c calcium for one patient.The following results were provided (reference range 2.10 to 2.55 mmol/l): on (b)(6) 2024, sid (b)(6) initial result= 4.072 mmol/l; repeat result= 2.54 mmol/l.There was no impact to patient management 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: 19710625
• Report Number: 3002809144-2024-00200
• Device Sequence Number: 8725081
• Product Code: CJY
• UDI-Device Identifier: 00380740135409
• UDI-Public: (01)00380740135409(17)250228(10)17995UN23
• 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): 08/09/2024

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: 07P57-30
• Device Lot Number: 17995UN23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• 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