MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY MAGNESIUM; MAGNESIUM,

Catalog Number	07D70-31
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/16/2018
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.No specific patient information was provided.Refer to related manufacturer report number 1628664-2018-00258 for the architect c16000 analyzer.
Event or Problem Description
The customer reported a falsely depressed architect magnesium result on the architect c16000 analyzer.Sample 1 generated an initial magnesium result of 1.0 mg/dl and retest on a second analyzer generated 2.0 mg/dl.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
After further evaluation it was determined that the clinical chemistry magnesium assay, list 07d70 was no longer considered the suspect medical device.The architect c16000 analyzer, list number 03l77-01, serial (b)(4) is the only suspect medical device.Mdr number 1628664-2018-00258 has been submitted and all further information will be documented under that mdr number.No longer considered a suspect medical device.

• Brand Name: CLINICAL CHEMISTRY MAGNESIUM
• Common Device Name: MAGNESIUM,
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 7647853
• Report Number: 1628664-2018-00257
• Device Sequence Number: 13484166
• 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,Followup
• Report Date (Section B): 08/06/2018

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 Catalogue Number: 07D70-31
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/17/2018
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 08/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT C16000 ANALYZER; ARCHITECT C16000 ANALYZER; LIST (B)(4), SERIAL (B)(4); LIST (B)(4), SERIAL (B)(4)