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

Catalog Number	03L79-22
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed calcium (ca) results generated on the architect c8000 processing module for a patient sample.The following data was provided (customer¿s reference range 2.10 - 2.55 mmol/l): (b)(6) 2024 sample id (b)(6) initial result = 0.69 mmol/l, same patient new sample obtained at another lab and result on unknown platform = 2.4 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely depressed calcium (ca) results generated on the architect c8000 processing module for a patient sample.The following data was provided (customer¿s reference range 2.10 - 2.55 mmol/l): (b)(6) 2024 sample id (b)(6) initial result = 0.69 mmol/l, same patient new sample obtained at another lab and result on unknown platform = 2.4 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Additional information sections d4 - expiration date and h4 - device mfg date.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, labeling review, and field data 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 without indication for any additional issue.A ticket search by lot indicates that there is normal complaint activity for lot number 63357un24, and the reagent lot performs as expected for this product.A review of the complaint trending report did not identify any trends for the issue for the product.The overall performance of the architect calcium reagent in the field was reviewed using data gathered from customers worldwide.The patient median results obtained with the complaint lot 63357un24 is within established limits and thus comparable to the historical lot performance, which confirms no systemic issue for the lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect calcium reagent, lot number 63357un24, was identified.

• 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: 20084683
• Report Number: 3002809144-2024-00254
• Device Sequence Number: 7811074
• Product Code: CJY
• UDI-Device Identifier: 00380740161491
• UDI-Public: (01)00380740161491(17)250404(10)63357UN24
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/08/2024

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: 03L79-22
• Device Lot Number: 63357UN24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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 C8000 REFURB-SEKAT, 01G06-97, (B)(6) ; ARC C8000 REFURB-SEKAT, 01G06-97, C802502
• Patient Sex: Unknown