MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CALCIUM

Catalog Number	03L79-31
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a false elevated calcium result when processing on the architect c8000.The initial result was 140 mg/l (14mg/dl).Retest yielded a result in normal range (no specific value provided).No impact to patient management was reported.
Additional Manufacturer Narrative
An investigation was performed for the customer issue and included a review of the complaint text, a search for similar complaints, tracking and trending, a review of historical performance and product labeling.A search by product lot number for other tickets similar to this issue found no similar complaints.The trend review by the product list number found no adverse or non-statistical trends related to this issue.World wide data was used to review historical performance and no unusual reagent lot performance was identified for lot 32860un18.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not 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: 8342753
• Report Number: 1628664-2019-00134
• Device Sequence Number: 1959150
• Product Code: CJY
• UDI-Device Identifier: 00380740005948
• UDI-Public: 00380740005948
• 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): 04/10/2019

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: 03L79-31
• Device Lot Number: 32860UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 04/10/2019
• 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 SYSTEM, LN 01G06-97; ARCHITECT C8000 SYSTEM, LN 01G06-97; SERIAL C802067; SERIAL C802067