MAUDE Adverse Event Report: ABBOTT GMBH CLINICAL CHEMISTRY MAGNESIUM

Model Number 03P6822

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.Manufacturing documentation was reviewed and no contributing factors to the complaint could be identified.Based on the available information, no product deficiency was identified.

Event Description

The customer stated that falsely elevated architect magnesium results were generated for two patients.No adverse impact to patient management was reported.Patient 1: initial result of 5.90 mg/dl retested at 1.9 mg/dl, sid (b)(6), tested on (b)(6) 2019.Patient 2: initial result of 6.0 mg/dl retested at 2.1 and 2.0 mg/dl, sid (b)(6), tested on (b)(6) 2019.

• Brand Name: CLINICAL CHEMISTRY MAGNESIUM
• Type of Device: MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: christian lee ; 100 abbott park road; dept 09b9, bldg cp01-3; abbott park, IL 60064-3537 ; 224668-294
• MDR Report Key: 10138431
• MDR Text Key: 221585996
• Report Number: 3002809144-2020-00460
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2020

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: 04/04/2020
• Device Model Number: 03P6822
• Device Catalogue Number: 03P68-22
• Device Lot Number: 07588UN19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1