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)
Date of Event	08/20/2017
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 indicated that an elevated calcium result of 5.09 mmol/l was generated on the architect c16000 analyzer.The sample was repeated and a result of 2.22 mmol/l was generated.There was no report of impact to patient management.
Additional Manufacturer Narrative
No returns were available for investigation.Customer complaint data was reviewed and no adverse or non-statistical trends were identified.The certificate of analysis for calcium reagent lot 36256un16 was reviewed and no issues were identified.The reagent passed all final release specifications.The calcium reagent package insert and the architect system operations manual were reviewed and were found to adequately address the issue.Based on the available information 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: 6849951
• Report Number: 1628664-2017-00329
• Device Sequence Number: 60228
• Product Code: CJY
• UDI-Device Identifier: 00380740005948
• UDI-Public: 00380740005948
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K981578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2017

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: 03/12/2018
• Device Catalogue Number: 03L79-31
• Device Lot Number: 36256UN16
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 08/28/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 09/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1