MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY MAGNESIUM

Catalog Number	07D70-31
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, labeling review, and device history review.No adverse trend was identified for the customer issue.Labeling was reviewed and found to be adequate.Device history review did not identify any issues that may have caused the customer issue.Review of the customer issue determined the specimens were not recentrifuged prior to testing.The customer stated the on board detergent washes are topped off and that the sample washes were not replaced daily.The operations manual maintenance procedures include instructions to change sample washes daily and to not top off reagents.No further discrepant results were noted and the quality controls were reported to be in range.Based on all available information and abbott diagnostics evaluation, no systematic issue was identified and no product deficiency was identified.
Event or Problem Description
The customer observed multiple falsely elevated magnesium results while using the clinical chemistry magnesium reagents.The customer uses reference range less than 2 mg/dl.The customer stated that the initial results were greater than 8 and the repeat results were less than 2, however specific results per patient were not provided.No impact to patient management was reported.

• Brand Name: CLINICAL CHEMISTRY MAGNESIUM
• Common Device Name: MAGNESIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6758705
• Report Number: 1628664-2017-00298
• Device Sequence Number: 19036787
• Product Code: JGJ
• UDI-Device Identifier: 00380740012939
• UDI-Public: 00380740012939
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 08/01/2017

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: 03/09/2019
• Device Catalogue Number: 07D70-31
• Device Lot Number: 79865UN17
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 08/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1