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

Catalog Number	02P24-40
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/09/2017
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 observed imprecise creatinine results while using the clinical chemistry creatinine reagents.The following data was provided.Sid (b)(6) initial 1.74, repeat 2.88, 2.69, 2.91 mg/dl, sid (b)(6) initial 1.05, repeat 2.24 mg/dl no impact to patient management was reported.
Additional Manufacturer Narrative
An abbott field service engineer (fse) was dispatched to the account and during inspection found gel residue on an analyzer needle/nozzle.Fse cleaned analyzer nozzles and washed cuvettes.After part 7-205228-01 nozzle, c4, 1, 4, 5 and cuvettes were cleaned, the analyzer was calibrated and the quality control returned normal results.The analyzer was returned to normal operation.Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, a labeling review, an instrument service review, and device history review.No returns were made available from the customer site for this evaluation.No adverse trend was identified for the customer issue.Labeling was reviewed and found to be adequate.The issue was resolved by cleaning contaminated or dirty parts.Service history review identified no contributing factors to the customer issue.Device history review did not identify any issues that may have caused the customer issue.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.Suspect medical device 4.Catalog number and lot number was changed to architect c4000 analyzer, list number 02p24-40, serial number (b)(4) from clinical chemistry creatinine list number 03l81-32 lot number unknown.Concomitant medical products was changed to chemistry creatinine list number 03l81-32 lot number 70406y600 from architect c4000 analyzer, list number 02p24-40, serial number (b)(4).The medical device manufacturer for both devices is the same.

• 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: 7135418
• Report Number: 1628664-2017-00525
• Device Sequence Number: 801798
• Product Code: JJE
• UDI-Device Identifier: 00380740005993
• UDI-Public: 00380740005993
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K981799
• 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,Followup
• Report Date (Section B): 01/25/2018

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 Catalogue Number: 02P24-40
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1