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

Model Number 3L79-21

Device Problem High Test Results (2457)

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

Event Date 02/29/2020

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.

Event 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.

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
• Type of Device: CALCIUM
• Manufacturer (Section D): ABBOTT LABORATORIES (IRVING IA/CC); 1915 hurd drive; irving TX 75038
• MDR Report Key: 9859515
• MDR Text Key: 225928706
• Report Number: 3016438761-2020-00005
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 03/29/2020
• Supplement Dates FDA Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 ANALYZER LIST 02P24-01; ARCHITECT C4000 ANALYZER LIST 02P24-01; SERIAL (B)(6); SERIAL (B)(6)