MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC MAGNESIUM

Catalog Number	07D70-21
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2019
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.There was no additional patient information provided by the customer.
Event or Problem Description
The customer reported falsely elevated magnesium (mg) results on two patients generated on the architect analyzer.The results provided were: on (b)(6) 2019 pt#1 = 7.8mg/dl / 2.1; pt#2 = 6.41 / 2.03mg/dl (normal range 1.3-2.3mg/dl).There was no reported impact to patient management.
Additional Manufacturer Narrative
During the subsequent site visit, the architect c4000, serial number (b)(4), instrument logs were reviewed by the field service engineer (fse).The error code 0550 [cuvette washing not completed, hardware failure, or user pressed stop] were noted prior to washing cuvettes, which could have caused contamination.The customer was notified that whenever the instrument is stopped by a user, a cuvette wash must be performed.After troubleshooting by the fse, all verification procedures passed and controls were within customer defined ranges.Precision performed on the magnesium assay with 20 reps cv=1.7%.Is within defined abbott claims.A review of tickets determined that there is no increase in complaints for magnesium, lot 45722un18, and no trends were identified for the complaint issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the clin chem magnesium, lot 45722un18.

• Brand Name: MAGNESIUM
• Common Device Name: MAGNESIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8523453
• Report Number: 1628664-2019-00311
• Device Sequence Number: 11237723
• Product Code: JGJ
• UDI-Device Identifier: 00380740012922
• UDI-Public: 00380740012922
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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: 12/03/2020
• Device Catalogue Number: 07D70-21
• Device Lot Number: 45722UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/23/2019
• 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,; ARCHITECT C4000 ANALYZER, LIST # 02P24-40,; SERIAL # (B)(4); SERIAL # (B)(4)