MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT CLINICAL CHEMISTRY MAGNESIUM

Catalog Number 03P68-21

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2014

Event Type  malfunction  

Event Description

The customer reports a falsely elevated clinical chemistry magnesium assay result generated for a patient sample tested on an architect c8000 analyzer.On (b)(6) 2014, an initial result of 0.31 mmol/l was generated.The customer has this value flagged as a critically low value and the sample was retested and generated a result of 0.90 mmol/l, which is within the assay package insert normal range of 0.66 to 1.07 mmol/l.The elevated result was verified.On (b)(6) 2014, the sample was retested and generated results of 0.31 and 0.31 mmol/l.This sample was sent to another lab for testing and generated a result of 0.34 mmol/l.This sample was then retested by the customer and generated a result of 0.32 mmol/l.On (b)(6) 2014, a second sample was tested at the other lab and generated a result of 0.49 mmol/l and then tested at the customer lab with a result of 0.46 mmol/l.There is no impact to patient management reported.

Manufacturer Narrative

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

Manufacturer Narrative

There were no returns made available from the customer for this evaluation.A review of the architect c8000 analyzer logs found the system's r1 probe smartwash for the ammonia assay and the cuvette smartwash for the urine magnesium assay were not programmed into the assay parameters.These smartwashes are designed to prevent carryover of magnesium from other sources and to allow the cleaning of cuvettes to come to completion, thereby preventing the assay reads from dirty cuvettes.The analyzer's logs also documented errors for sample aspiration, reagent aspiration and cuvette wash cycle not completed.A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation.The architect system operations manual and the clinical chemistry magnesium assay package insert contain information to address the current customer issue.Based on the available information from the customer site and from the results of this evaluation, there is no evidence to reasonably suggest a product malfunction occurred.The issue was isolated to one patient's samples as no observation of this issue is documented for quality control samples.Catalog# corrected from 07d70-31 to 03p68-21.

• Brand Name: ARCHITECT CLINICAL CHEMISTRY MAGNESIUM
• Type of Device: MAGNESIUM
• 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: 4140104
• MDR Text Key: 4792567
• Report Number: 1628664-2014-00216
• Device Sequence Number: 1
• Product Code: JGJ
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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
• Report Date: 09/22/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2015
• Device Catalogue Number: 03P68-21
• Device Lot Number: 45120UN14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 10/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000 ANALYZER LN: 01G06-11; SN: (B)(4)