MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY MAGNESIUM

Catalog Number 07D70-31

Device Problem High Test Results (2457)

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

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported an initial false elevated architect magnesium result.Sample (b)(6)generated an initial result of 6.97 mg/dl and repeat generated a result of 2.1 mg/dl.The customer uses a normal range of 1.6 to 2.6 mg/dl.No specific patient information was provided and no impact to patient management was reported.

Manufacturer Narrative

Further investigation of the customer's issue included a review of the complaint text, a search for similar complaints, review of customer instrument logs, review of manufacturing records, and a review of labeling.Review of complaint activity did not identify any adverse or non-statistical trends for the architect magnesium assay.No other complaints were identified for reagent lot 12922un17.The customer's instrument logs were reviewed.The suspect magnesium sample reaction graph was unremarkable and the absorbances reflect a high magnesium result.During the review multiple sample aspiration errors were noted to have occurred on the day the suspect sample results were generated.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.Based on the available information, no systemic issue or deficiency of the architect magnesium assay 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: 7037177
• MDR Text Key: 93063650
• Report Number: 1628664-2017-00441
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740012939
• UDI-Public: 00380740012939
• 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,Followup
• Report Date: 12/18/2017

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: 05/03/2019
• Device Catalogue Number: 07D70-31
• Device Lot Number: 12922UN17
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 11/16/2017
• Supplement Dates Manufacturer Received: 12/01/2017
• Supplement Dates FDA Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2017
• 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