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 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6).Section a patient information: no further patient information was provided.The complaint investigation included a review of the complaint text, complaint activity trending data and labeling associated with the magnesium assay.Although a return sample was available it was not necessary for the investigation.Review of the complaint text indicated that the sample was retested at the customer site on the same instrument, and on another instrument with similar lower normal results.Additionally, qc results were reported to be within range.A review of tickets determined that there is normal complaint activity for reagent lot#: 72837un20.Tracking and trending reports were reviewed and no trends were identified.Historical performance of reagent lot#: 72837un20 was evaluated using world-wide field data from.The patient data was analyzed, and compared to an established control limit.This evaluation indicated that the patient median result for lot#: 72837un20 is within the established control limits.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 systemic issue, or deficiency was identified for the magnesium reagent, lot#: 72837un20.

Event Description

The customer obtained a falsely elevated architect magnesium result while using the architect c4000 analyzer.Sample id: (b)(6), generated an initial result of 6.6 mg/dl, and repeat 1.96 mg/dl.No impact to patient management was reported.

• Brand Name: MAGNESIUM
• Type of Device: PHOTOMETRIC METHOD, 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, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 10825505
• MDR Text Key: 215965696
• Report Number: 3002809144-2020-01106
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181748
• 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: 11/11/2020

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: 08/17/2021
• Device Model Number: 03P6822
• Device Catalogue Number: 03P68-22
• Device Lot Number: 72837UN20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2020
• Initial Date FDA Received: 11/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1