MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CALCIUM

Catalog Number 03L79-21

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2019

Event Type  malfunction  

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 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.

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
• Type of Device: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9410086
• MDR Text Key: 214820690
• Report Number: 1628664-2019-00741
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740005931
• UDI-Public: 00380740005931
• Combination Product (y/n): N
• PMA/PMN Number: K981578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 12/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 ANALYZER LIST 02P24-40.; ARCHITECT C4000 ANALYZER LIST 02P24-40.; SERIAL (B)(4).; SERIAL (B)(4).