MAUDE Adverse Event Report: ABBOTT GMBH MAGNESIUM

Model Number	03P6822
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planckring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10571115
• Report Number: 3002809144-2020-00989
• Device Sequence Number: 13751102
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC C4 PROC MOD, 02P24-01, (B)(6) ; ARCHITECT C4000 PROCESSING MODULE; LIST 02P24-01, SERIAL (B)(6)