MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CALCIUM

Catalog Number	03L79-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2018
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.
Event or Problem Description
The customer reported multiple false elevated architect calcium results on the architect c16000 analyzer.Sample id 9175964jp generated an initial result of 5.13 mmol/l and retest of 2.20 mmol/l.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
Review of complaint activity for lot 98314un17 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.Manufacturing documentation for the assay 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
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7975515
• Report Number: 1628664-2018-01946
• Device Sequence Number: 1487839
• Product Code: CJY
• UDI-Device Identifier: 00380740005931
• UDI-Public: 00380740005931
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K981578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2019
• Device Catalogue Number: 03L79-21
• Device Lot Number: 98314UN17
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 01/29/2019
• 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 C16000 ANALYZER; ARCHITECT C16000 ANALYZER; LIST 03L77-01, SERIAL (B)(4); LIST 03L77-01, SERIAL (B)(4)