MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CALCIUM

Catalog Number	03L79-31
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.No customer returns were available for evaluation.A review of ticket trending for architect calcium reagent product lot number (61157un18) did identify one additional complaint that was similar to this issue.In that case, no deficiency was identified.The trend review by the product list number found no trends related to this issue.Worldwide field data was reviewed to evaluate the historical performance of lot 61157un18.The patient median result for the lot was comparable with all other lots in the field and within established limits, confirming no systemic issue.Labeling was reviewed and found to adequately address the issue under review.No product deficiency was identified.This issue was previously reported under mdr number 1415939-2019-00170 under the same suspect medical device but an incorrect manufacturer name, city and state.
Event or Problem Description
The customer reported a falsely decreased calcium result generated on the architect c8000 analyzer on one patient.Results provided: sid (b)(6) on (b)(6) 2019 = 2.3 mg/dl / repeated same sample: sid (b)(6) on (b)(6) 2019 = 9.6 mg/dl.(normal range: 8.5-10.5 mg/dl) there was no impact to patient management reported.

• Brand Name: CALCIUM
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9215203
• Report Number: 1628664-2019-00676
• Device Sequence Number: 2589289
• Product Code: CJY
• UDI-Device Identifier: 00380740005948
• UDI-Public: 00380740005948
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K981578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2019

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: 02/06/2020
• Device Catalogue Number: 03L79-31
• Device Lot Number: 61157UN18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1