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

Model Number	03P6832
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11438922
• Report Number: 3002809144-2021-00158
• Device Sequence Number: 4092083
• Product Code: JGJ
• UDI-Device Identifier: 00380740161637
• UDI-Public: 00380740161637
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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: 10/11/2021
• Device Model Number: 03P6832
• Device Catalogue Number: 03P68-32
• Device Lot Number: 01965UN20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 06/23/2021
• 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)