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	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 - patient identifier: patient 1 sid = (b)(6), patient 2 sid = (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated alinity c calcium results generated on the alinity c processing module for two patients.The samples were repeated on another instrument which generated lower results.The following data was provided: customer¿s reference range: 8.8 mg/dl to 10.2 mg/dl.(b)(6) 2024 (b)(6) alinity result = 17.8 mg/dl, repeat result on the atlia = 7.97 mg/dl.(b)(6) 2024 (b)(6) alinity result = 23.3 mg/dl, repeat result on the atlia = 7.57 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated alinity c calcium results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.Return testing was not completed as returns were not available.A ticket search by lot indicates the reagent lot is performing as expected for this product.A ticket trending review did not identify any trends for the issue for the product.The device history record review did not identify any non-conformances or deviations with lot 74196un23 and complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Based on this investigation, no systemic issue or deficiency was identified for the alinity c calcium reagent lot 74196un23.
Event or Problem Description
The customer observed falsely elevated alinity c calcium results generated on the alinity c processing module for two patients.The samples were repeated on another instrument which generated lower results.The following data was provided: customer¿s reference range: 8.8 mg/dl to 10.2 mg/dl.(b)(6) 2024 (b)(6) alinity result = 17.8 mg/dl, repeat result on the atlia = 7.97 mg/dl.(b)(6) 2024 (b)(6) alinity result = 23.3 mg/dl, repeat result on the atlia = 7.57 mg/dl.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: 20031233
• Report Number: 3002809144-2024-00244
• Device Sequence Number: 6508309
• Product Code: CJY
• UDI-Device Identifier: 00380740132613
• UDI-Public: (01)00380740132613(17)250228(10)74196UN23
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 08/28/2024

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: 74196UN23
• 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: 08/01/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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