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

Catalog Number	02P24-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem Description
The customer stated that falsely elevated architect lactate dehydrogenase (ldh) result were generated for patient samples.The customer's normal range is 125 - 220 u/l.No adverse impact to patient management was reported.The following data was provided.Sample id (b)(6): initial 360, repeat 181 u/l; sample id (b)(6): initial 297, repeat 220 u/l; sample id (b)(6): initial 384, repeat 238 u/l; sample id (b)(6): initial 282, repeat 221 u/l.
Additional Manufacturer Narrative
A field service engineer inspected the architect c16000 analyzer, sn (b)(6), and cleaned and replaced parts.The likely causes were determined to be the r2a tubing (aero rgt tbg r2a) , bellows, and peristaltic head tubing.A review of the service history for the architect (b)(6) revealed no additional issues were reported post replacement of these 3 parts.Historical data of the r2a tubing, bellows, and peristaltic head tubing did not identify any trends or systemic issues.The calculated erratic rate for the c16000 were acceptable.Manufacturing documentation was reviewed and contains sufficient information with regards to patient result flagging, limitations of result interpretation, maintenance, component replacement, error codes, and troubleshooting the customer issue.Based on the information within the complaint record no systemic issue or deficiency was identified for the architect c16000 system.

• 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: 8735081
• Report Number: 1628664-2019-00468
• Device Sequence Number: 13937458
• Product Code: JJE
• UDI-Device Identifier: 00380740004033
• UDI-Public: 00380740004033
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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
• Report Date (Section B): 08/07/2019

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: 02P24-01
• Device Lot Number: 50494UN18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 08/07/2019
• 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; LACTATE DEHYDROGENASE, LIST 02P56-21; LIST 02P24-01, SERIAL (B)(6); LOT 50494UN18