MAUDE Adverse Event Report: ABBOTT LABORATORIES (IRVING IA/CC) CALCIUM

Model Number 3L79-31

Device Problem High Test Results (2457)

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

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

No further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed a falsely elevated calcium result generated on the architect c8000 processing module for one sample.The following data was provided (customer's reference range: 8.4 to 10.2 mg/dl) : (b)(6) 2020 initial result = 16.1 mg/dl, repeat = 11.1 mg/dl, new draw specimen: initial result = 9.1 mg/dl.No impact to patient management was reported.

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for the complaint lot 41159un19.Trending review determined did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Retesting of another sample gave expected results.Customer mentioned factors such as hemolysis or sample handling could have affected the initial result.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the calcium reagent lot number 41158un19 was identified.

• Brand Name: CALCIUM
• Type of Device: CALCIUM
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 10260450
• MDR Text Key: 213901412
• Report Number: 3016438761-2020-00119
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

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: 11/27/2020
• Device Model Number: 3L79-31
• Device Catalogue Number: 03L79-31
• Device Lot Number: 41159UN19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000 PROCESSING MODULE; ARCHITECT C8000 PROCESSING MODULE; LIST 01G06-11, SERIAL (B)(6); LIST 01G06-11, SERIAL (B)(6)