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 Consequences Or Impact To Patient (2199)
Date of Event	08/30/2017
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 false elevated architect magnesium results for two patients.The customer uses a normal range of 1.6 to 2.6 mg/dl.The following discrepant results were provided: patient 3: initial 7.3 and repeat 1.5 mg/dl.Patient 5: initial 6.9 and repeat 1.7 mg/dl.No specific patient information was provided.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of the customer instrument logs and a review of labeling.Review of complaint activity associated with the magnesium assay and reagent lot 36339un17 did not identify any trends associated with the issue.The customer instrument logs were reviewed.This review found the reaction graph for the questioned sample ids were unremarkable, however each result was flagged with cntl.This flag indicates these results were generated after the control results failed and these results should not be reported.The instrument history logs also showed multiple occurrences of aspiration error codes which could indicate inadequate centrifugation or sample preparation issues.Labeling was reviewed and adequately addresses the issue observed by the customer.Based on the available information and this investigation, 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: 6870692
• Report Number: 1628664-2017-00341
• Device Sequence Number: 827472
• Product Code: JGJ
• UDI-Device Identifier: 00380740012939
• UDI-Public: 00380740012939
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/28/2017

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: 01/06/2019
• Device Catalogue Number: 07D70-31
• Device Lot Number: 36339UN17
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/01/2017
• Supplement Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1