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)
Date of Event	01/21/2019
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.Patient information: no specific patient information was provided.
Event or Problem Description
The customer reported a false elevated architect magnesium result.The initial sample generated a result of 6.1 mg/dl.A new sample was collected and generated a result of 2.2 mg/dl.The initial sample was retested and generated a result of 2.0 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the architect (b)(4) and determined the bellows set, including rod & fitting required replacement because the bellows was noted to be cracked.Replacement of the bellows set resolved the issue and was identified as the likely cause.A review of tracking and trending data in the product monitoring review for clinical chemistry systems revealed no systemic issues or adverse trends related to the erratic result issue described in this complaint.The erratic result rates were reviewed and are within acceptable limits with no trends identified.Historical data for the bellows set was reviewed and no adverse trend, systemic issues, or nonconformances were identified.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.Based on the information within the complaint record no systemic issue or deficiency was identified for the architect c4000 analyzer.
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 suspect medical device have been corrected: brand name: architect c4000 analyzer; common device name: automated chemistry analyzer; product code: jje; concomitant medical products and therapy dates: architect magnesium, list 07d70-21, lot 78493un18.

• 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: 8283015
• Report Number: 1628664-2019-00062
• Device Sequence Number: 10780781
• Product Code: JJE
• UDI-Device Identifier: 00380740012922
• UDI-Public: 00380740012922
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 03/22/2019

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: 01/22/2019
• Supplement Date Received by Manufacturer: 01/30/2019; 03/12/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 02/04/2019; 03/22/2019
• 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 ANALYZER, LN 02P24-40; CLINICAL CHEMISTRY MAGNESIUM; CLINICAL CHEMISTRY MAGNESIUM; LN 07D70-21, LOT 78493UN18; LN 07D70-21, LOT 78493UN18; SERIAL (B)(4).