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

Catalog Number 02P24-40

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer generated falsely increased magnesium results while using the clinical chemistry magnesium assay.The customer provided the following result data (provided reference range 1.6 - 2.6 mg/dl): sid (b)(6): (b)(6) 2016: initial: 6.34 mg/dl, retest 2.42 mg/dl.Sid: (b)(6): (b)(6) 2016: initial 7.36 mg/dl, retest 2.15 mg/dl.No impact to patient management was reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a service history review, abbott field service evaluation, a search for similar complaints, and a review of labeling.A service history review for this instrument revealed no subsequent complaints of discrepant/erratic results being reported.An abbott field service engineer (fse) completed troubleshooting of the instrument.This involved part replacements per normal troubleshooting procedures, which resolved the issue.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency and no malfunction of the architect c4000 analyzer, list number 02p24, was identified.

Manufacturer Narrative

The device evaluation was reassessed and concluded that a malfunction occurred.However, no systemic issue or product deficiency was identified for the architect c4000 analyzer, list number (b)(4), was identified.

• Brand Name: ARCHITECT C4000 ANALYZER
• Type of Device: AUTOMATED CHEMISTRY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 5748977
• MDR Text Key: 48502269
• Report Number: 1628664-2016-00179
• Device Sequence Number: 0
• Product Code: JGJ
• Reporter Country Code: AU
• PMA/PMN Number: K980367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02P24-40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2016
• Initial Date FDA Received: 06/24/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/28/2016; 04/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1