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

Model Number 03P6822

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2021

Event Type  malfunction  

Event 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.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.No further information was provided.

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 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
• Type of Device: 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
• MDR Text Key: 284815894
• Report Number: 3002809144-2021-00697
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4000 INTGR, 02P24-40, (B)(6); ARC C4000 INTGR, 02P24-40, (B)(6)