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)
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.Patient information: no specific patient information was provided.
Event or Problem Description
The customer reported a falsely elevated architect calcium result.Sample id ia0900329ss generated an initial result of 10.92 meq/l.The sample was retested multiple times ranging from 3.51 meq/l to 4.98 meq/l.The customer uses a normal range of 4.09 to 5.58 meq/l.No specific patient information was provided.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Update 04dec2018: section, catalog # updated to 03l79-21.
Additional Manufacturer Narrative
Review of the complaint activity for the calcium assay did not identify atypical complaint activity.The customers instrument logs were reviewed.This review found the customer does not perform all the required maintenance on the architect c8000 analyzer.During the review no identifiable quality control sample analysis was found.The lack of routine instrument maintenance and quality control testing may have contributed to the customers issue.Manufacturing documentation for the calcium assay did not identify any issues.Additionally, labeling was reviewed and sufficiently addresses the customers 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: 8006894
• Report Number: 1628664-2018-01972
• Device Sequence Number: 1386539
• Product Code: CJY
• UDI-Device Identifier: 00380740005948
• UDI-Public: 00380740005948
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 01/17/2019

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: 10/10/2018
• Supplement Date Received by Manufacturer: 11/12/2018; 01/09/2019
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 12/04/2018; 01/17/2019
• 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 01G06-11; ARCHITECT C8000, LIST 01G06-11; ARCHITECT C8000, LIST 01G06-11; SERIAL C802810; SERIAL C802810; SERIAL C802810