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

Model Number IMMULITE 2000 XPI - TG

Device Problem Low Test Results (2458)

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

Event Date 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens customer care center.A customer service engineer (cse) was dispatched to the customer site.The instrument was reviewed, and maintenance is up to date.The cse tested quality control (qc) with 5 replicates and found it acceptable.Two additional patient samples were tested with multiple trial and the results were found to be consistent.The customer processed qc daily for the past 30 days and all results were found acceptable.Siemens headquarters support center (hsc) is reviewing the data provided by the customer.The cause for the discordant falsely elevated tg sample results is unknown.Siemens is investigating the issue.Mdr 2432235-2019-00250 was filed for the same event.

Event Description

Discordant, falsely depressed thyroglobulin (tg results were obtained using immulite 2000 xpi instrument.The results were not reported to the physician(s).The same sample was repeated using the same immulite 2000 xpi instrument with higher and lower results.Additional samples were collected and repeated first on the same immulite 2000 xpi and then on another immulite at a different facility.The customer could not confirm the correct result after multiple trials.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated tg results.

Manufacturer Narrative

The initial mdr 2432235-2019-00351 was filed on 30-sep-2019.Additional information (14-nov-2019): the customer provided two samples collected from the same patient drawn in two different tube types to siemens for internal testing.Siemens technical support laboratory (tsl) performed the study below: tsl adjusted one immulite 2000 with tg reagent lots 371 and 404.The adjustment was verified successfully with triplicate run of the quality control (qc) found to be within range.The provided patient samples were tested in replicates of ten using tg reagent lots 371 and 404.Siemens reproduced the customer's observation on tg imprecision from the provided patient samples.Siemens headquarters support center (hsc) reviewed the data provided by the customer and tsl.Hsc identified the following probable cause for the tg imprecision for the two patient samples: the presence of lipid and/or fibrin due to inadequate centrifugation/separation.The presence of lower affinity anti-thyroglobulin antibodies.The presence of heterophilic antibodies.The presence of other interferants.The imprecision with tg is isolated to the two samples only.The hsc did not identify a product problem.No other issues have been reported by the customer post the service visit and the service actions performed resolved the reported issue.The instrument is performing within specification.No further evaluation of the device is required.Mdr 2432235-2019-00350-s1 was filed for the same event.

• Brand Name: IMMULITE 2000 XPI - TG
• Type of Device: IMMULITE 2000 XPI - TG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, LL55 4EL; EI LL55 4EL
• MDR Report Key: 9137656
• MDR Text Key: 220624390
• Report Number: 2432235-2019-00351
• Device Sequence Number: 1
• Product Code: MSW
• Combination Product (y/n): N
• PMA/PMN Number: K982468
• 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: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: IMMULITE 2000 XPI - TG
• Device Catalogue Number: 10381648
• Device Lot Number: 371
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR