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

Model Number 03P6832

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2020

Event Type  malfunction  

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.The patient sample was reanalyzed using the same reagent with no issues; acceptable results were generated.A review of tickets determined that there is normal complaint activity for lot 35289un20.Review of tracking and trending reports did not identify any related trends for the issue for the product.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 systemic issue or deficiency of the architect magnesium reagent, lot number 35289un20 was identified.

Event Description

The customer reported falsely elevated magnesium results generated on the architect c8000 processing module for two patients.The results provided from the samples collected on (b)(6) 2020 were: patient 1 initial result was 6.3 mg/dl, repeated 1.9 mg/dl; patient 2 initial result was 6.3 mg/dl, repeated 1.9 mg/dl; (customer reference range 1.7 mg/dl to 2.8 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: 11021520
• MDR Text Key: 241306786
• Report Number: 3002809144-2020-01191
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161637
• UDI-Public: 00380740161637
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2021
• Device Model Number: 03P6832
• Device Catalogue Number: 03P68-32
• Device Lot Number: 35289UN20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2020
• 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