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

Catalog Number	07P57-30
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported imprecise alinity c calcium results generated by the alinity c processing modules for a patient.The following data was provided: customer¿s adjusted calcium range: 2.20 to 2.60 mmol/l.Sid (b)(6): on (b)(6) 2023 initial result = 1.26 mmol/l (b)(6) with unknown reagent lot#).Repeat result = 2.34 mmol/l (b)(6) with unknown reagent lot#).There was no impact to patient management reported.
Additional Manufacturer Narrative
Section a1 - patient identifier: complete sample id is (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, a ticket trending review, a device history record review, and a labeling review.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and support the complaint issue.A ticket search by lot could not be performed as the likely cause lot is unknown.A review of tracking and trending data for the alinity c calcium assay did not identify an increase in complaint activity related to the complaint issue.A review of the device history record did not identify any non-conformances or deviations with the likely cause list number and the complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.Based on this investigation, no systemic issue or deficiency was identified with the alinity c calcium reagent, lot number unknown.
Event or Problem Description
The customer reported imprecise alinity c calcium results generated by the alinity c processing modules for a patient.The following data was provided: customer¿s adjusted calcium range: 2.20 to 2.60 mmol/l.Sid (b)(6): on (b)(6) 2023 initial result = 1.26 mmol/l (b)(6) with unknown reagent lot#).Repeat result = 2.34 mmol/l (b)(6) with unknown reagent lot#).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: 21489797
• Report Number: 3002809144-2025-00064
• Device Sequence Number: 18246256
• Product Code: CJY
• UDI-Device Identifier: 00380740135409
• UDI-Public: (01)00380740135409
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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 Catalogue Number: 07P57-30
• 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: 02/06/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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); ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Sex: Unknown