MAUDE Adverse Event Report: ABBOTT GERMANY CLINICAL CHEMISTRY MAGNESIUM

Catalog Number 03P68-22

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Event Description

The account generated a false elevated architect magnesium of 6.1 mg/dl on sid (b)(6) that repeated 1.5, 1.6 mg/dl.The account uses a reference range of 1.6 to 2.6 mg/dl.No impact to patient management was reported.

Manufacturer Narrative

Instrument logs were reviewed with error codes 0550 cuvette washing not completed, hardware failure or user pressed stop were noted prior to washing cuvettes, which could have caused contamination.The customer was notified that whenever the instrument is stopped by user, a cuvette washes 6052 must be performed.Additionally, the customer states at that time of the event quality control (qc) results were erratic but the next day the qc was in range.The customer stated that it is possible that the magnesium erratic result is specific sample related.There were no adverse trends identified during the trend review and lot search did not identify an increase in complaint activity for the current issue for the complaint lot.No nonconformances were identified related to this issue.A review of the product labeling concluded that the issue is sufficiently addressed.No product deficiency was identified.

• 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: 9294077
• MDR Text Key: 219780771
• Report Number: 3002809144-2019-00833
• 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: 12/23/2019

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: 10/17/2019
• Initial Date FDA Received: 11/07/2019
• Supplement Dates Manufacturer Received: 12/03/2019
• Supplement Dates FDA Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 LIST 2P24-40.; ARCHITECT C4000 LIST 2P24-40.; SERIAL (B)(4).; SERIAL (B)(4).
• Patient Age: 53 YR