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 Consequences Or Impact To Patient (2199)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evalulation is in process.Follow up report will be submitted when the evaluation is complete.
Event or Problem Description
The account generated false elevated architect calcium of 3.99 mmol/l when processing on the architect c8000.The sample repeated architect calcium of 2.34 mmol/l.No specific patient information was provided.No impact to patient management was reported.
Additional Manufacturer Narrative
The customer replaced the sample and r1 probes on the architect c8000 analyzer.No customer returns were available for evaluation.A search of the complaint database by product lot number found other tickets similar to this issue.These tickets were closed with no deficiency found.The trend review by the product list numbers found no adverse or non-statistical trends related to this issue.Review of patient data in the field shows the calcium patient population result medians are similar for each product across multiple customers, instruments, and reagent lots.Review of product labeling revealed adequate labeling for the handling of reagents, handling of patient samples, interpretation of assay results, and troubleshooting this complaint issue.No 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: 7732985
• Report Number: 1628664-2018-00785
• Device Sequence Number: 1589062
• 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,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2018

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: 10/27/2018
• Device Catalogue Number: 03L79-31
• Device Lot Number: 45322UN17
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/04/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 09/27/2018
• 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; SERIAL (B)(4); SERIAL (B)(4)