MAUDE Adverse Event Report: ABBOTT GMBH MAGNESIUM

Model Number 03P6822

Device Problem High Test Results (2457)

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

Event Date 05/01/2020

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 a falsely elevated magnesium (mg) result generated on the architect c4000 analyzer on one patient.Results provided: (b)(6) 2020 pt1 = 6.1 / 1.7 / 1.7 mg/dl.Normal range: 1.6-2.6 mg/dl.No impact to patient management was reported.

Manufacturer Narrative

After further evaluation, the suspect medical device was changed to architect c4000, list 2p24 (irving, tx as manufacturing site) and submitted under manufacturer report number 3016438761-2020-00103.All further information will be documented under mdr number 3016438761-2020-00103.

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for lot 33531un19 and there are no trends for the product related to patient results.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no s deficiency of the magnesium reagent, lot number 33531un19 was identified.

• Brand Name: MAGNESIUM
• Type of Device: MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10087725
• MDR Text Key: 228393497
• Report Number: 3002809144-2020-00413
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2020

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 Expiration Date: 05/16/2020
• Device Model Number: 03P6822
• Device Catalogue Number: 03P68-22
• Device Lot Number: 33531UN19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/01/2020
• Initial Date FDA Received: 05/26/2020
• Supplement Dates Manufacturer Received: 06/02/2020; 06/03/2020
• Supplement Dates FDA Received: 06/02/2020; 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 ANALYZER LIST 02P24-01.; ARCHITECT C4000 ANALYZER LIST 02P24-01.; ARCHITECT C4000 ANALYZER LIST 02P24-01.; SERIAL (B)(6).; SERIAL (B)(6).; SERIAL (B)(6).