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

Model Number 03P6822

Device Problem High Test Results (2457)

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

Event Date 12/08/2020

Event Type  malfunction  

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 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.

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
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11050608
• MDR Text Key: 223455782
• Report Number: 3002809144-2020-01203
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• 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: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4000 INTGR, 02P24-40, C402043; ARC C4000 INTGR, 02P24-40, C402043