MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY MAGNESIUM

Catalog Number	07D70-31
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2017
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 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.
Additional 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
• Common Device Name: MAGNESIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7037177
• Report Number: 1628664-2017-00441
• Device Sequence Number: 13771914
• Product Code: JGJ
• UDI-Device Identifier: 00380740012939
• UDI-Public: 00380740012939
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K981791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2019
• Device Catalogue Number: 07D70-31
• Device Lot Number: 12922UN17
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1