MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT C4000 ANALYZER; AUTOMATED CHEMISTRY ANALYZER

Catalog Number	02P24-40
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.
Event or Problem Description
The customer reported falsely elevated architect magnesium results.Sample id (b)(6) generated one elevated result of 7.4 mg/dl and multiple lower results of 1.9, 2.6 and 2.1 mg/dl.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from clinical chemistry magnesium, list number 07d70-21, abbott manufacturing inc.To architect c4000 analyzer, list number 02p24-40, abbott manufacturing inc.Subsequently the following sections in d suspect mdical device have been corrected: brand name: architect c4000 analyzer; common device name: automated chemistry analyzer; product code: (b)(4).Concomitant medical products and therapy dates: architect magnesium, list 07d70-21, lot 78493un18.
Additional Manufacturer Narrative
An abbott field service representative inspected the analyzer and found the internal probe wash bellows were leaking and the cuvette wipers were warn.To resolve the issue the bellows and cuvette wiper were replaced, which were identified to be the likely causes.The service history for the architect serial (b)(4) identified no additional contributing factors and no subsequent issues have been reported.A review of historical data for the bellows and cuvette wiper did not identify any adverse trends or systemic issues.A review of architect clinical chemistry systems tracking and trending data in the product monitoring review revealed no systemic issues or adverse trends related to the erratic result issue described in this complaint.The architect csystems erratic result rates were also within acceptable limits with no trends identified.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect c4000 analyzer was identified.

• Brand Name: ARCHITECT C4000 ANALYZER
• Common Device Name: AUTOMATED CHEMISTRY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8122357
• Report Number: 1628664-2018-02092
• Device Sequence Number: 11313412
• Product Code: JJE
• UDI-Device Identifier: 00380740012922
• UDI-Public: 00380740012922
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K981791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2019

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 Catalogue Number: 02P24-40
• Device Lot Number: 78493UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 12/08/2018; 01/29/2019
• Initial Report FDA Received Date: 12/01/2018
• Supplement Report FDA Received Date: 12/13/2018; 01/31/2019
• 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 C4000, LIST 02P24,; ARCHITECT MAGNESIUM, LIST 07D70-21; ARCHITECT MAGNESIUM, LIST 07D70-21; LOT 78493UN18; LOT 78493UN18; SERIAL C401424
• Outcome Attributed to Adverse Event: Other