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 11/07/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported false elevated magnesium (mg) results for 2 patients while running on the architect c4000 analyzer.The following data was provided (reference range: 1.6 to 2.6 mg/dl): on (b)(6) 2020 sample 1: mg = initial = 8.6 mg/dl, repeat = 2.1 mg/dl.On (b)(6) 2020 sample 2: mg = initial = 7.3 mg/dl, repeat = 2.5 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 abbott gmbh, deu in section d of this report to architect c4000, list number 01r24-56, manufacturing site abbott laboratories (irving ia/cc).Mdr number 3016438761-2020-00324-00 has been submitted and all further information will be documented under that mdr number.H3 other text : after further evaluation, the suspect medical device was changed from magnesium, list number 03p68-22, manufacturing site abbott gmbh, wiesbaden, deu in section d of this report to architect c4000, list number 01r24-56, manufacturing site abbott laboratories (irving ia/cc).Mdr number 3016438761-2020-00324-00 has been submitted and all further information will be documented under that mdr number.

• 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: 10865344
• MDR Text Key: 241306354
• Report Number: 3002809144-2020-01123
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

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: 03P6822
• Device Catalogue Number: 03P68-22
• Device Lot Number: 85056UN20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 12/01/2020
• Supplement Dates FDA Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4000 SA REF BRAZIL, 01R24-56, C460867; ARC C4000 SA REF BRAZIL, 01R24-56, C460867