MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM; MAGNESIUM FLEX® REAGENT CARTRIDGE

Catalog Number K3057

Device Problem Low Test Results (2458)

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

Event Date 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics has received customer complaints for the dimension vista magnesium (mg) lot 15063ba.The complaints were related to erroneous low results on a small number of reagent wells.Siemens healthcare diagnostics issued an urgent medical device recall communication (b)(4) dated september 2015 instructing customers to discontinue use and discard any remaining inventory of the affected lot and to contact siemens healthcare diagnostics for replacement product.Data collected from the customer complaints shows that there is the potential for under-recovery on certain wells for quality control(qc) and patient sample results.When this issue occurred, the under-recovery ranged from -0.3 mg/dl [0.12 mmol/l] to -1.6 mg/dl [0.66 mmol/l].The average under-recovery was -1.0 mg/dl [0.41 mmol/l].This issue is demonstrating a low frequency of occurrence with an estimate one (1) in every 10,000 tests may be affected.Repeating the sample on a new well or a new flex cartridge resolves the issue.This issue is likely to be detected by quality control (qc) or calibrators if they are run on the affected wells of reagent.Siemens healthcare diagnostics has confirmed that the customer received the urgent medical device recall communication (b)(4).They had not discarded the lot.The issue has now been resolved by the customer discontinuing use of the lot.

Event Description

Discrepant depressed magnesium (mg) results were obtained on patient samples.Patient results were reported to physicians.The account repeated the samples with an alternate dimension vista instrument and higher results were obtained and corrected results were reported.Patient treatment was not altered or prescribed on the basis of the falsely depressed mg results.There was no report of adverse health consequences as a result of the falsely depressed mg results.

• Brand Name: DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM
• Type of Device: MAGNESIUM FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 5266175
• MDR Text Key: 32662434
• Report Number: 2517506-2015-00208
• Device Sequence Number: 1
• Product Code: JGJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/12/2015

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: No Information
• Device Expiration Date: 03/03/2016
• Device Catalogue Number: K3057
• Device Lot Number: 15063BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/03/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 2517506-09292015-006-C
• Patient Sequence Number: 1