MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY MAGNESIUM

Catalog Number	07D70-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2019
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 stated that a falsely elevated architect magnesium result of 6.2 mg/dl was reported for a patient sample that retested at 2.6 mg/dl.A corrected report was issued.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Complaint searches determined that there is normal complaint activity for the likely cause lot.Labeling was reviewed and found to be adequate.In- house testing was performed with representative lots of clinical chemistry magnesium reagent.Testing was performed over a period of 21 days using bio-rad lyphocheck unassayed chemistry controls as validity controls.Technopath controls level 1 and level 3, bio-rad lyphocheck unassayed chemistry controls, a normal pooled serum and plasma were tested as patient samples.The reagents wedges were depleted in order to run the last time points at low volume.All control materials, bio-rad and technopath, generated results within the established ranges.Curve stability testing was completed at day 21 and met the acceptance criteria.Based on the available information, no product deficiency 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: 8416696
• Report Number: 1628664-2019-00193
• Device Sequence Number: 1473517
• Product Code: JGJ
• UDI-Device Identifier: 00380740012922
• UDI-Public: 00380740012922
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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: 09/07/2020
• Device Catalogue Number: 07D70-21
• Device Lot Number: 95220UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 04/19/2019
• 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 C4000 ANALYZER; LIST 02P24-40, SERIAL (B)(4)