MAUDE Adverse Event Report: ABBOTT GMBH MAGNESIUM

Model Number 03P6822

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated magnesium results for two patient samples tested on the architect c4000 analyzer.The following data was provided: sid (b)(6): initial result 6.7, repeat 1.9, 1.9 mg/dl (repeated with sid (b)(6)).Sid (b)(6): initial result 2.7, repeat 1.1, 1.0 mg/dl (repeated with sid (b)(6)).The customer uses normal range 1.6 - 2.6 mg/dl.No impact to patient management was reported.

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for lot 04426un19.Trending review determined no adverse trend for falsely elevated results for the product.Return testing was not completed as returns were not available.Historical performance of reagent lot 04426un19 was evaluated using world wide data from abbottlink.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 04426un19 is within the established control limits.Therefore, no unusual reagent lot performance was identified.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 architect magnesium reagent, lot 04426un19.

• Brand Name: MAGNESIUM
• Type of Device: MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9899357
• MDR Text Key: 189247623
• Report Number: 3002809144-2020-00245
• 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: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2020
• Device Model Number: 03P6822
• Device Catalogue Number: 03P68-22
• Device Lot Number: 04426UN19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 04/27/2020
• Supplement Dates FDA Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 ANALYZER; ARCHITECT C4000 ANALYZER; LN 02P24-40, SN (B)(6) ; LN 02P24-40, SN (B)(6)