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 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

This issue was previously reported under mdr number 3016438761-2020-00217 under a different suspect medical device and manufacturer name, city and state.An evaluation is still in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer observed a falsely elevated magnesium result generated on the architect c4000 processing module for one sample.The following data was provided (customer's normal range: 1.6 to 2.6 mg/dl): sid (b)(6) initial result = 6.5 mg/dl, repeat after the physician questioned the result = 1.6 mg/dl no impact to patient management was reported.

Manufacturer Narrative

A review of tickets was performed for lot number 25242un19.The ticket search determined that there is normal complaint activity for the likely cause lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.The historical performance of reagent lot 25242un19 was evaluated using field data.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 25242un19 is within the established control limits.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Customer support determined the customer had not updated to the current assay version of this assay which includes a smartwash update.Use error caused the issue as the customer was not using the current version of the assay.No further occurrences of complaint issue were observed after the assay version update.Based on the investigation no systemic issue or deficiency of the magnesium assay for lot 33532un19 was identified.Based on the investigation magnesium reagent lot 25242un19 is performing as intended, no systemic issue or deficiency of the magnesium reagent was identified.

• Brand Name: MAGNESIUM
• Type of Device: MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planckring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10571115
• MDR Text Key: 208507773
• Report Number: 3002809144-2020-00989
• 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
• Report Date: 10/23/2020

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: 01/31/2021
• Device Model Number: 03P6822
• Device Catalogue Number: 03P68-22
• Device Lot Number: 25242UN19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 10/19/2020
• Supplement Dates FDA Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4 PROC MOD, 02P24-01, (B)(6) ; ARCHITECT C4000 PROCESSING MODULE; LIST 02P24-01, SERIAL (B)(6)