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

Model Number 03P6832

Device Problem High Test Results (2457)

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

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Was this device serviced by a third party?: no.All available patient information was included.Additional patient details are not available.A review of tickets found one similar complaint for magnesium lot 01965un20, but no trends were identified for false elevated results.Return testing was not completed as returns were not available.Historical performance of reagent lot 01965un20 was evaluated using world wide data from (b)(4).The population median results for the lot are within established limits.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Labeling was reviewed and probable cause was identified: contamination may occur from other sources for falsely elevated magnesium results.Based on the investigation no product deficiency was identified for the architect magnesium reagent, lot 01965un20.

Event Description

The customer observed falsely elevated magnesium (mag) result on c4000 processing module for one patient.The results provided were: on (b)(6) 2021, sid (b)(6), initial=7.3 mg/dl/repeated=2.1 mg/dl and 2.2 mg/dl/previous history=2.1 mg/dl.Laboratory reference range for magnesium=1.6 to 2.6 mg/dl there was no reported impact to patient management.

Manufacturer Narrative

This follow up is being submitted to include d8 and h6 information previously submitted using the h10 section in their respective fields.

• Brand Name: MAGNESIUM
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11438922
• MDR Text Key: 266415483
• Report Number: 3002809144-2021-00158
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161637
• UDI-Public: 00380740161637
• Combination Product (y/n): N
• PMA/PMN Number: K181748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2021
• Device Model Number: 03P6832
• Device Catalogue Number: 03P68-32
• Device Lot Number: 01965UN20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2021
• 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)