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

Model Number	03P6822
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated magnesium results for several patients on an architect c4000 analyzer.The following data was provided (customer¿s reference range is 1.6-2.6 mg/dl): sample id: (b)(6) initial result was 3.6, repeat was 1.3 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from magnesium, list number 03p68-22, manufacturing site wiesbaden, germany, which was submitted under manufacturer report number 3002809144-2020-01203-00 to architect c4000 analyzer, list number 02p24-40, manufacturing site irving, texas, which was submitted under mdr number 3016438761-2021-00016-00.All further information will be documented under mdr number 3016438761-2021-00016-00.

• 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: 11050608
• Report Number: 3002809144-2020-01203
• Device Sequence Number: 2651717
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181748
• Number of Events Summarized: 1
• Summary Report (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): 01/18/2021

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: 10/02/2021
• Device Model Number: 03P6822
• Device Catalogue Number: 03P68-22
• Device Lot Number: 01964UN20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 01/18/2021
• 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, C402043; ARC C4000 INTGR, 02P24-40, C402043