MAUDE Adverse Event Report: ABBOTT GMBH MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM

Model Number 03P6822

Device Problem High Test Results (2457)

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

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information is included.Additional patient details are not available.

Event Description

The customer reported a false elevated architect magnesium result for one patient.The customer provided: sid: (b)(6); initial = 0.85 mmol/l, repeats 0.88 mmol/l, 2.51 mmol/l (normal range: 0.62 mmol/l to 1.07 mmol/l).Other test results, that were not magnesium, provided by the customer, were also reviewed, and none met reporting criteria.There was no reported impact to patient management.

Manufacturer Narrative

The evaluation of the customer¿s issue included a search for similar complaints, ticket trending review, labeling review, device history record review and field data review.A review of tickets determined that there is normal complaint activity for lot 64034un20.Trending review determined no trend for falsely elevated results for the product.Returns were not available.The patient sample was tested triplicate with one elevated result and two similar lower normal results.Qc results were reported to be within range.Historical performance of reagent lot 64034un20 was evaluated using world-wide data.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 64034un20 is within the established control limits.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 all available information no product deficiency was identified.

• Brand Name: MAGNESIUM
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10991722
• MDR Text Key: 220923300
• Report Number: 3002809144-2020-01175
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (y/n): N
• PMA/PMN Number: K181748
• 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: 01/08/2021

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: 04/09/2021
• Device Model Number: 03P6822
• Device Catalogue Number: 03P68-22
• Device Lot Number: 64034UN20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/11/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4000 INTGR, 02P24-40, C400309; ARC C4000 INTGR, 02P24-40, C400309; ARC C4000 INTGR, 02P24-40, C400309