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

Model Number	3L79-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for patient information, patient identifier = sid= (b)(6).A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated calcium results on architect c16000 processing module for one (b)(6) female patient.The results provided were: on (b)(6) 2022 sid (b)(6) initial=16.51 mg/dl /repeated auto dilution= < 10 mg/dl /repeated without dilution=9.58 mg/dl.Laboratory reference range for calcium=8.8 to 10.0 mg/dl there was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history records for architect calcium reagent, lot number 06762un20.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Trending review determined no adverse trend for the issue for the product.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect calcium reagent, lot number 06762un20 was identified.

• Brand Name: CALCIUM
• Common Device Name: AZO DYE, CALCIUM
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 13759119
• Report Number: 3016438761-2022-00111
• Device Sequence Number: 12079881
• Product Code: CJY
• UDI-Device Identifier: 00380740005931
• UDI-Public: 00380740005931
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 04/06/2022

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: 03/09/2022
• Device Model Number: 3L79-21
• Device Catalogue Number: 03L79-21
• Device Lot Number: 06762UN20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2021
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC C16K PRC MOD, 03L77-01, C1601970; ARC C16K PRC MOD, 03L77-01, C1601970
• Patient Age: 72 YR
• Patient Sex: Female