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

Model Number	3L79-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/29/2020
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.
Event or Problem Description
The customer reported a falsely elevated calcium result generated on the architect c4000 on one patient.Results provided: (b)(6) = 15.1 / 10.1 mg/dl (normal range: 8.4-10.4 mg/dl).No impact to patient management was reported.
Additional Manufacturer Narrative
The evaluation of complaint data for the product and likely cause lot 07310un19 identified normal complaint activity and there are no trends for the product related to patient results.No customer returns were available for evaluation.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.An analyzer log review was performed and discovered that the customer's issue with calcium occurred while also processing the architect hba1c assay.After editing the smart wash configuration for the calcium, the customer has had no more issues.Based on the investigation no product deficiency was identified for the architect calcium assay lot# 07310un19.

• Brand Name: CALCIUM
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 9859515
• Report Number: 3016438761-2020-00005
• Device Sequence Number: 3436204
• Product Code: CJY
• UDI-Device Identifier: 00380740005931
• UDI-Public: 00380740005931
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/30/2020

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: 06/07/2020
• Device Model Number: 3L79-21
• Device Catalogue Number: 03L79-21
• Device Lot Number: 07310UN19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 03/29/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 03/30/2020
• 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 C4000 ANALYZER LIST 02P24-01; ARCHITECT C4000 ANALYZER LIST 02P24-01; SERIAL (B)(6); SERIAL (B)(6)