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	10/02/2018
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 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.
Additional 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
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7980680
• Report Number: 1628664-2018-01948
• Device Sequence Number: 19203434
• Product Code: CJY
• UDI-Device Identifier: 00380740005931
• UDI-Public: 00380740005931
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 01/11/2019

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
• Operator of Device: 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 Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 01/11/2019
• 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 C8000, LIST 01G06; ARCHITECT C8000, LIST 01G06; SERIAL (B)(4); SERIAL (B)(4)