MAUDE Adverse Event Report: ABBOTT GMBH CALCIUM; AZO DYE, CALCIUM

Catalog Number	03L79-32
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a falsely elevated calcium result generated on the architect c16000 analyzer on a patient.Results provided: pt 2: 3.06 / 3.5 / 2.53 / 2.54 / 2.60 mmol/l (reference range: 2.1-2.8 mmol/l).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
A review of tickets determined that there is normal complaint activity for lot number 63360un24.Trending review of list number 3l79 determined no trends for false low patient results due to the product.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.To further investigate the customer¿s issue, the historical performance of reagent lot number 63360un24 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 the lot numbers in the field for lot number 63360un24 is within the established control limits.Therefore, no unusual reagent performance was identified.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of architect calcium reagent lot number 63360un24was identified.
Event or Problem Description
The customer reported a falsely elevated calcium result generated on the architect c16000.Analyzer on a patient.Results provided: pt 2: 3.06 / 3.5 / 2.53 / 2.54 / 2.60 mmol/l (reference range: 2.1-2.8 mmol/l) no impact to patient management was reported.

• Brand Name: CALCIUM
• 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: 20877230
• Report Number: 3002809144-2024-00346
• Device Sequence Number: 8928938
• Product Code: CJY
• UDI-Device Identifier: 00380740161507
• UDI-Public: (01)00380740161507(17)250404(10)63360UN24
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/30/2024

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: 04/04/2025
• Device Catalogue Number: 03L79-32
• Device Lot Number: 63360UN24
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• 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: ARC C16K PRC MOD, 03L77-01, (B)(6).; ARC C16K PRC MOD, 03L77-01, (B)(6).
• Patient Sex: Unknown