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

Model Number	IMMULITE 2000 - CARB
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens customer care center.Adjustments and controls were verified and were as expected.Siemens headquarters support center (hsc) is reviewing the data provided by the customer.The cause for the discordant falsely elevated carb sample results is unknown.Siemens is investigating the issue.Mdr 2432235-2019-00349 was filed for the same event.
Event or Problem Description
Two discordant, falsely elevated carbamazepine (carb) results were obtained using immulite 2000.The initial result was not reported to the physician(s).A first repeat result using the same immulite 2000 xpi was also considered discordant.Additional repeat results using alternate siemens and non-siemens method were lower.The repeat result from the alternate siemens method (dimension exl) 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 carb results.
Additional Manufacturer Narrative
Siemens filed initial mdr(b)(4) on (b)(6)2019.Additional information (18-dec-2019): siemens headquarters support center (hsc) reviewed the information provided by the customer.Hsc requested the patient sample to be sent to siemens technical support laboratory (tsl) for further investigation.Tsl performed side by side testing of the patient sample on immulite 2000, advia centaur, and dimension exl.The sample was run on all three platforms along with 5 patient samples known to be in the carbamazepine therapeutic range.The investigation revealed that the results from immulite 2000 were elevated compared to the other two platforms.The samples were found above the therapeutic range with immulite 2000.Serial dilution of the patient sample provided by the customer showed some level of interference using immulite 2000.Hsc reviewed the information for use (ifu) for immulite 2000 carbamazepine and noted that phenobarbital does not interfere with the testing.Hsc could not rule-out an unknown interferent with this patient sample to be the cause of the elevated carb results.The immulite 2000 carbamazepine assay is performing as expected.Sections h6 and h10 were updated to reflect the additional information.The instrument is performing within specification.No further evaluation of the device is required.Mdr 2432235-2019-00349-s1 was filed for the same event.

• Brand Name: IMMULITE 2000 - CARB
• Common Device Name: IMMULITE 2000 - CARB
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, LL55 4EL; EI LL55 4EL
• MDR Report Key: 9257936
• Report Number: 2432235-2019-00404
• Device Sequence Number: 1879547
• Product Code: KLT
• UDI-Device Identifier: 00630414961095
• UDI-Public: 00630414961095
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K000007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: IMMULITE 2000 - CARB
• Device Catalogue Number: 10381550
• Device Lot Number: 245
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR