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

Model Number	3L79-22
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 depressed calcium results generated on the architect c8000 processing module for one patient.The results were questioned.The customer repeated and the results were higher.The following data was provided: sid (b)(6) processed (b)(6) 2023 initial result = 0.529.Repeat results = 2.76, 2.75, 2.72, 2.75, 2.75 repeated on another instrument = 2.75.Uom = mmol/l.Reference range = 2.15 mmol/l to 2.60 mmol/l no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely depressed calcium results 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 available.Trending review by did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with list number 03l79 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.As part of the troubleshooting the sample was retested and generated higher results.Sample was also repeated on another instrument and result was within normal range.Based on our investigation, no systemic issue or deficiency with the calcium assay for lot 62202un22 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16876438
• Report Number: 3002809144-2023-00222
• Device Sequence Number: 5830144
• Product Code: CJY
• UDI-Device Identifier: 00380740161491
• UDI-Public: 00380740161491
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/09/2023

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: 04/27/2023
• Device Model Number: 3L79-22
• Device Catalogue Number: 03L79-22
• Device Lot Number: 62202UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• 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