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

Model Number	03P6822
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained a falsely elevated magnesium result while using the architect c4000 analyzer.On (b)(6) 2021 sample id (b)(6) generated a result of 8.0 mg/dl.The physician questioned the result and a new sample ((b)(6) generated 0.9 mg/dl.The original sample was retested and generated 0.8 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.No further information was provided.
Additional Manufacturer Narrative
Investigation of the customer's issue included review of the information provided by the customer, analyzer instrument logs, complaint activity, trending data, device history records, labeling and field data.Return testing was not completed as returns were not available.Review of the customer's instrument logs confirmed the customer's observation.Additionally, it was noted that instrument maintenance was performed just prior to the analysis of the elevated magnesium result.Daily maintenance is completed with solutions with high magnesium content which could cause contamination of the cuvette.Review of trending data for the architect magnesium assay did not identify any trends.Review of the device history records did not identify any non-conformances or deviations related to the complaint issue.Labeling was reviewed and adequately addresses the customer's issue.Using worldwide field data the performance of reagent lot 87180un21 was assessed.The patient median value for the lot was within established baselines with no shift observed, indicating the lot is performing acceptable.Based on this investigation, no systemic issue or deficiency for the architect magnesium reagent lot was identified.
Event or Problem Description
The customer obtained a falsely elevated magnesium result while using the architect c4000 analyzer.On november 22, 2021 sample id (b)(6) generated a result of 8.0 mg/dl.The physician questioned the result and a new sample (41437477 generated 0.9 mg/dl.The original sample was retested and generated 0.8 mg/dl.No impact to patient management was reported.

• 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: 12985141
• Report Number: 3002809144-2021-00697
• Device Sequence Number: 14876566
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2021

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 Expiration Date: 03/10/2022
• Device Model Number: 03P6822
• Device Catalogue Number: 03P68-22
• Device Lot Number: 87180UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 12/26/2021
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• 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 C4000 INTGR, 02P24-40, (B)(6); ARC C4000 INTGR, 02P24-40, (B)(6)
• Patient Sex: Unknown