MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CALCIUM

Catalog Number	03L79-21
Medical Device Problem Code	Low Test Results (2458)
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.
Event or Problem Description
The customer reported a false decreased architect calcium result of less than 20 mg/l.Repeat results were 94.72 and 93.79 mg/l.No impact to patient management was reported.
Additional Manufacturer Narrative
An investigation was performed for the customer issue and included a review of compliant text, a search for similar complaints, a review of historical data and a review of labeling.The trend review and lot search did not identify an increase in complaint activity for the current issue and no additional issues were identified.The review did not identify any trends associated with this issue.Labeling was reviewed and found to be adequate.Based on all available formation and abbott diagnostics' complaint investigation no product deficiency 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: 8235561
• Report Number: 1628664-2019-00021
• Device Sequence Number: 10816823
• 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): 03/17/2019

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: 08/23/2019
• Device Catalogue Number: 03L79-21
• Device Lot Number: 84637UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 03/17/2019
• 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 C16000, LIST 03L77-97; ARCHITECT C16000, LIST 03L77-97; SERIAL (B)(4). ; SERIAL (B)(4).