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

Model Number	3L79-31
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 10260450
• Report Number: 3016438761-2020-00119
• Device Sequence Number: 11352778
• Product Code: CJY
• UDI-Device Identifier: 00380740005948
• UDI-Public: 00380740005948
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K981578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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 C8000 PROCESSING MODULE; ARCHITECT C8000 PROCESSING MODULE; LIST 01G06-11, SERIAL (B)(6); LIST 01G06-11, SERIAL (B)(6)