MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY MAGNESIUM

Catalog Number 07D70-21

Device Problem Low Test Results (2458)

Patient Problem No Code Available (3191)

Event Date 02/25/2015

Event Type  Injury  

Event Description

The customer observed a falsely depressed magnesium result for several patients on the architect c8000 analyzer.The customer reported that falsely depressed magnesium results of less than 0.7 mg/dl were observed on (b)(6) 2015 for 10 patient samples.The customer reported that the magnesium assay was calibrated before the samples in question were tested and suspects the same level of calibrator was used for both calibrator level 1 and level 2 as the cal absorbances were similar for both calibrator levels.The samples in question were repeated and generated normal results ranging from 1.6 to 2.3 mg/dl.One patient had an unnecessarily magnesium rider via iv infusion due to the falsely depressed result.No further patient or event details were available.

Manufacturer Narrative

(b)(4).Unnecessary dose of magnesium delivered via iv.Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, a review of labeling and an instrument log review.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.Review of logs from the customer's system found the first calibration attempt on (b)(6) 2015 failed with error - calibrators out of order.The suspect patient samples were then tested, followed by controls that were too low.Recalibration failed with error - insufficient cal replicates.The assay was recalibrated without error and controls were run which appeared to be acceptable as the results are similar to results prior to this issue.Based on all available information and abbott diagnostics' complaint investigation, the assay performed as intended and no product deficiency was identified.

• Brand Name: 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: 4625052
• MDR Text Key: 5658064
• Report Number: 1628664-2015-00109
• Device Sequence Number: 1
• Product Code: JGJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2016
• Device Catalogue Number: 07D70-21
• Device Lot Number: 58799UN14
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2015
• Initial Date FDA Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000 LN 01G06-11 (B)(4); CALIBRATOR LN 01E69-03 LOT 40235M500
• Patient Outcome(s): Other