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 06/02/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided by the customer.

Event Description

The customer reported falsely elevated magnesium results on one patient generated on the architect analyzer.The results provided were: on (b)(6) 2019 sid (b)(6) = 8.7 / 2.28mg/dl (1.6-2.6mg/dl).There was no reported impact to patient management.

Manufacturer Narrative

Upon review the abbott customer technical advocate determined that both discrepant results were measured in the same cuvette.The samples were retested on the same system and generated lower results.The quality control (qc) results were reported to be acceptable.A search for similar complaints for the magnesium reagent did not identify any additional complaints and no trends were identified for the product issue.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.Based on the investigation no product deficiency was identified for the magnesium reagent, lot 46458un18.

• 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: 8733198
• MDR Text Key: 149701497
• Report Number: 3002809144-2019-00359
• 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: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2019
• Device Catalogue Number: 03P68-22
• Device Lot Number: 46458UN18
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 ANALYZER, LIST # 02P24-01; ARCHITECT C4000 ANALYZER, LIST # 02P24-01; SERIAL # (B)(4); SERIAL # (B)(4)