MAUDE Adverse Event Report: ABBOTT 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 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier = sid= (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated magnesium (mag)results on architect c4000 processing module for multiple patients.The results provided were: sid: (b)(6); initial mag result=1.9 mg/dl/ repeated=6.3 mg/dl there was no reported impact to patient management.

Manufacturer Narrative

After further evaluation, the suspect medical device was changed to architect c4000 processing module, list 2p24 (irving, tx as manufacturing site) and submitted under manufacturer report number 3016438761-2020-00269-00.All further information will be documented under mdr number 3016438761-2020-00269-00.

• Brand Name: MAGNESIUM
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10697784
• MDR Text Key: 211927833
• Report Number: 3002809144-2020-01022
• 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: 10/28/2020

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
• Device Operator: Health Professional
• Device Model Number: 03P6832
• Device Catalogue Number: 03P68-32
• Device Lot Number: 11805UN20
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 10/22/2020
• Supplement Dates FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4000 INTGR, 02P24-40, C402282; ARC C4000 INTGR, 02P24-40, C402282; ARC C4000 INTGR, 02P24-40, C402282