MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CALCIUM

Catalog Number 03L79-31

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.A second suspect medical device was added on sept 8, 2019.This information has also been previously reported under manufacturer report 1628664-2019-00569.

Event Description

The customer observed a falsely elevated calcium result on the architect c8000 analyzer.The following data was provided: initial 3.87, repeat 3.03, 2.51 mmol/l.There was no impact to patient management reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of data, and a review of labeling.No adverse trend was identified for the customer's issue.No return patient sample was available.The certificate of analysis (coa) for calcium ln 3l79 lot number 61157un18 demonstrated that the product met all acceptance requirements prior to being released for distribution.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: CLINICAL CHEMISTRY CALCIUM
• Type of Device: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9106750
• MDR Text Key: 190167572
• Report Number: 1628664-2019-00630
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740005948
• UDI-Public: 00380740005948
• 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: 10/23/2019

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: 03L79-31
• Device Lot Number: 61157UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/08/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 10/23/2019
• Supplement Dates FDA Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000 ANALYZER; ARCHITECT C8000 ANALYZER; LIST 01G06-11 , SERIAL (B)(4); LIST 01G06-11 SN (B)(4)