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	07/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the analyzer history log from the customer system showed multiple occurrences of sample aspiration and "cuvette wash cycle not completed" errors.The maintenance log shows the wash cuvettes procedure was not performed after the occurrences of the cuvette wash errors as recommended in the operations manual.There were no returns from the customer site for this evaluation.Ticket searches by reagent lots found no other complaints similar to the current issue.The trend review for the last 12 months by list numbers found no adverse or non-statistical trends.The architect clin chem calcium reagent package insert and the architect system operations manual contain information to address the current customer issue.Based on the results of this evaluation and the information from the customer site, a product malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site.Use error may have contributed to the customer issue as error codes indicate sample handling issue and/or dirty cuvettes, which may contribute to false results.However, no systemic issue or product deficiency was identified.Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided.
Event or Problem Description
The customer reports that from (b)(6) 2016, one patient generated the following clin chem (b)(6).The patient is taking a daily calcium carbonate supplement and one dose of vitamin d.

• Brand Name: CLINICAL CHEMISTRY CALCIUM
• Common Device Name: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6565321
• Report Number: 1628664-2017-00212
• Device Sequence Number: 133542
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2017

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: 02/25/2017
• Device Catalogue Number: 03L79-31
• Device Lot Number: 85776UN15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 05/12/2017
• 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 ANALYZER LN: 01G06-11; SN: (B)(4)