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

Catalog Number	03L79-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
The customer reported falsely elevated calcium generated from an architect c8000 and provided the following data for 1 patient: customer reference range ¿ normal is up to 2.55 mmol/l sample id (b)(6)initial result was 3.547, repeat results were 2.526; 2.497; 2.494; 2.506; 2.504; 2.503; 2.492; 2.487; 2.495: 2.493: 2.499.Per the customer the discrepant result(s) were not reported out of the laboratory.There was no reported impact to patient management.
Event or Problem Description
The customer reported falsely elevated calcium generated from an architect c8000 and provided the following data for 1 patient: customer reference range ¿ normal is up to 2.55 mmol/l sample id (b)(6) initial result was 3.547, repeat results were 2.526; 2.497; 2.494; 2.506; 2.504; 2.503; 2.492; 2.487; 2.495: 2.493: 2.499.Per the customer the discrepant result(s) were not reported out of the laboratory.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not yet available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Device history review did not identify any associated non-conformances or deviations related to the customer issue with the complaint lot.Ticket search by lot did not identify an increase in complaint activity for the complaint lot.Trending review has not identified any trends.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified for the calcium reagent lot 72897un23.

• 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: 18840832
• Report Number: 3002809144-2024-00060
• Device Sequence Number: 12589818
• Product Code: CJY
• UDI-Device Identifier: 00380740161491
• UDI-Public: (01)00380740161491(17)241218(10)72897UN23
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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): 05/15/2024

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: 12/18/2024
• Device Catalogue Number: 03L79-22
• Device Lot Number: 72897UN23
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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 C8 PROC MOD, 01G06-11, (B)(6). ; ARC C8 PROC MOD, 01G06-11, (B)(6).
• Patient Sex: Unknown