MAUDE Adverse Event Report: ABBOTT GMBH MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM

Model Number	03P6832
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The account generated false elevated architect magnesium that repeated lower after recalibration.On (b)(6) 2021, sid (b)(6) generated architect magnesium of 3.1 mg/dl that was reported out of the lab.The account recalibrated and repeated the sample with architect magnesium of 1.3 mg/dl that was reported with a corrected report.The account uses a magnesium normal range of 1.8 to 2.6 mg/dl.No specific patient information was provided.No impact to patient management was reported.
Additional Manufacturer Narrative
Patient identifier does not contain enough character spaces, the entire id is (b)(6).An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Additional information was provided that expired architect magnesium reagent lot 42219un20 used on (b)(6) 2021 for testing patient samples.The architect magnesium package insert instructs the user not use reagents beyond the expiration date.Based on the additional information, this event is no longer reportable and no further followup will be provided.
Event or Problem Description
Additional information was provided that expired architect magnesium reagent lot 42219un20 used on (b)(6) 2021 for testing patient samples.

• Brand Name: MAGNESIUM
• Common Device Name: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12894301
• Report Number: 3002809144-2021-00682
• Device Sequence Number: 3644025
• Product Code: JGJ
• UDI-Device Identifier: 00380740161637
• UDI-Public: 00380740161637
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 12/10/2021

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 Model Number: 03P6832
• Device Catalogue Number: 03P68-32
• Device Lot Number: 42219UN20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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: ARC C8 PROC MOD, 01G06-11, (B)(6); ARC C8 PROC MOD, 01G06-11, (B)(6)
• Patient Sex: Unknown