MAUDE Adverse Event Report: ABBOTT GERMANY CLINICAL CHEMISTRY MAGNESIUM

Catalog Number 03P68-22

Device Problem High Test Results (2457)

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

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information: patient identifier: multiple = sid (b)(6); sid (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer reported falsely elevated magnesium (mg) results on two patients generated on the architect analyzer.The results provided were: on (b)(6) 2019 sid (b)(6) = 2.92 / 0.77 mmol/l (normal range 0.66-1.07 mmol/l); sid (b)(6) = 3.85 / 0.82 / 0.83 mmol/l.There was no reported impact to patient management.

Manufacturer Narrative

A ticket search by lot 07588un19 found normal complaint activity and no trends related to this issue.The customer performed troubleshooting on the instrument, the cuvettes wash volumes were adjusted, and the probes and mixers were checked, and all were within specification.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.Technical bulletin (tb) 1041-2012 provides information about elevated magnesium patient results that may occur due to contamination from other sources of magnesium.Magnesium is found in multiple reagents and in architect csystem water bath additive and ict sample diluent.This tb contains troubleshooting information for magnesium issues that may be due to system specific conditions.Based on the investigation no product deficiency was identified for the clinical chemistry magnesium, lot 07588un19.

• Brand Name: CLINICAL CHEMISTRY MAGNESIUM
• Type of Device: MAGNESIUM
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9104389
• MDR Text Key: 159972207
• Report Number: 3002809144-2019-00573
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

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 Catalogue Number: 03P68-22
• Device Lot Number: 07588UN19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 11/25/2019
• Supplement Dates FDA Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C16000 ANALYZER, LN 03L77-01; ARCHITECT C16000 ANALYZER, LN 03L77-01; SERIAL # (B)(4). ; SERIAL # (B)(4).