MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CALCIUM

Model Number	3L79-21
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/02/2019
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 decreased calcium result generated on the architect c16000 on one patient.Results provided: 02dec2019 = 1.09 / 2.14 / 2.6 mmol/l, customers normal range: newborn (mmol / l), premature 1.55 to 2.75, 0 to 10 days 1.90 to 2.60, 10 days to 24 months 2.25 to 2.75.No impact to patient management was reported.
Additional Manufacturer Narrative
A review of ticket trending for architect calcium reagent product lot number (19417un19) did not identify any complaint that was similar to this issue.The trend review by the product list number found no trends related to this issue.No customer returns were available for evaluation.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.No product deficiency was identified.

• Brand Name: CALCIUM
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9712112
• Report Number: 1628664-2020-00059
• Device Sequence Number: 11494946
• Product Code: CJY
• UDI-Device Identifier: 00380740005931
• UDI-Public: 00380740005931
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/28/2020

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: 07/09/2020
• Device Model Number: 3L79-21
• Device Catalogue Number: 03L79-21
• Device Lot Number: 19417UN19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 02/28/2020
• 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 C16000 SYSTEM LIST 03L77-01; ARCHITECT C16000 SYSTEM LIST 03L77-01; SERIAL (B)(6); SERIAL (B)(6)