MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI - CMB

Model Number IMMULITE 2000 XPI - CMB

Device Problem High Test Results (2457)

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

Event Date 08/13/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens customer care center (ccc).Siemens headquarters support center (hsc) is reviewing the provided results, the instrument files, and the error logs.The cause for the discordant, falsely elevated cmb sample result is unknown.Siemens is investigating the issue.

Event Description

One discordant, falsely elevated creatine kinase isoenzyme - mb (cmb) result was obtained on immulite 2000 xpi instrument.The initial result was not reported to the physician(s).The same sample was repeated using the same immulite 2000 xpi instrument.The repeat result was considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated cmb result.

Manufacturer Narrative

Siemens filed initial mdr 2432235-2019-00312 on 5-sep-2019.Additional information (15-oct-2019): siemens headquarters support center (hsc) has reviewed the information provided by the customer.Hsc observed that the original instrument was swapped out to a new immulite 2000 xpi instrument after several repair attempts.The issue was not resolved after the instrument replacement which ruled out a hardware issue.Siemens field application specialist (fas) was dispatched to the customer site to observe the sample handling process for 5 days and found several issues.Fas provided proper sample handling recommendations to the customer.No product performance issue was identified.No other issues have been reported by the customer post fas visit and the actions performed resolved the reported issue.The instrument is performing within specification.No further evaluation of the device is required.Sections h6 and h10 were updated to reflect the additional information.

• Brand Name: IMMULITE 2000 XPI - CMB
• Type of Device: IMMULITE 2000 XPI - CMB
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, LL55 4EL; EI LL55 4EL
• MDR Report Key: 8967190
• MDR Text Key: 219482387
• Report Number: 2432235-2019-00312
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• PMA/PMN Number: K004002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: IMMULITE 2000 XPI - CMB
• Device Catalogue Number: 10381033
• Device Lot Number: 253
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR