MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CALCIUM

Catalog Number 03L79-21

Device Problem High Test Results (2457)

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

Event Date 10/02/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The account generated a falsely elevated patient result (sample id (b)(6)) when using architect calcium assay.Initial result: 4.268 mmol/l.Sample rerun result: 2.415 mmol/l.No impact to patient management reported.Patient age, gender, race and ethnicity were not provided.

Manufacturer Narrative

Review of complaint activity for lot 53233un18 did not identify an increase in complaint activity.Tracking and trending report review for the architect calcium assay did not identify any adverse or non-statistical trends that require further investigation.The customer instrument logs were reviewed and all quality control results were within range indicating the reagents are performing as expected.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect calcium assay 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: 7980680
• MDR Text Key: 126111408
• Report Number: 1628664-2018-01948
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

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: 05/12/2019
• Device Catalogue Number: 03L79-21
• Device Lot Number: 53233UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/18/2018
• Supplement Dates Manufacturer Received: 01/11/2019
• Supplement Dates FDA Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000, LIST 01G06; ARCHITECT C8000, LIST 01G06; SERIAL (B)(4); SERIAL (B)(4)