MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CALCIUM

Catalog Number	03L79-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2019
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.All available patient information was included.Additional patient details are not available.Patient identifier: complete sid: (b)(6).
Event or Problem Description
The customer reported a falsely elevated calcium result generated on the architect c4000 analyzer on one patient.Results provided: (b)(6) 2019 sid (b)(6) = 17.2 / 9.4 / 9.6 mg/dl.Normal range: (8.4-10.2 mg/dl).No impact to patient management was reported.
Additional Manufacturer Narrative
A review of ticket trending for architect calcium reagent product lot number (61158un18) and product list number did not find other complaints that was similar to this issue.The certificate of analysis for calcium ln 3l79 lot number 61158un18 demonstrates that it was released within the final release specifications and met all of abbotts acceptance requirements prior to being released for distribution.Labeling was reviewed and found to adequately address the issue under review.No product deficiency was identified.

• Brand Name: CALCIUM
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9410086
• Report Number: 1628664-2019-00741
• Device Sequence Number: 17193993
• Product Code: CJY
• UDI-Device Identifier: 00380740005931
• UDI-Public: 00380740005931
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K981578
• Number of Events Summarized: 1
• Summary Report (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): 12/14/2019

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: 02/06/2020
• Device Catalogue Number: 03L79-21
• Device Lot Number: 61158UN18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 12/14/2019
• 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: ARCHITECT C4000 ANALYZER LIST 02P24-40.; ARCHITECT C4000 ANALYZER LIST 02P24-40.; SERIAL (B)(4).; SERIAL (B)(4).