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

Catalog Number 03P68-32

Device Problem High Test Results (2457)

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

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.The complaint investigation included a search for similar complaints, and the review of complaint text, trending data, labelling, and device history records.Historical performance of the reagent lot was evaluated using worldwide data from abbottlink.Trending review determined no adverse trend for the issue for the product.Historical complaint review determined there is normal complaint activity for lot number 81717un21.Device history record review did not show any potential non-conformances, or deviations.Labelling was reviewed and found to adequately address the issue under review.Worldwide data from abbottlink was reviewed and determined that patient median result for the lot is comparable with other lots in the field and within established baselines confirming no systemic issue for the lot.Based on the investigation, no systemic issue or deficiency for lot number 81717un21 was identified.

Event Description

The customer stated that a falsely elevated architect magnesium result of 6.7 mg/dl was generated for a patient sample that retested at 2.0 mg/dl.The initial result was not reported to the physician.The normal range for adults is 1.6 - 2.6 mg/dl.No adverse impact to patient management was reported.

• Brand Name: MAGNESIUM
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12576334
• MDR Text Key: 274734107
• Report Number: 3016438761-2021-00353
• Device Sequence Number: 1
• Product Code: JGJ
• 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
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2022
• Device Catalogue Number: 03P68-32
• Device Lot Number: 81717UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2021
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ARC C4000 INTGR, 02P24-40, C402806