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

Model Number	IMMULITE 2000 XPI - CAL
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens customer care center.A customer service engineer (cse) was dispatched to the customer site.The cse checked quality control (qc) and adjustment, component alignments and voltages, and ran qc 10 times with satisfactory results.The cse repeated undiluted samples that resulted <2 and/or with error and found that the instrument was performing within specifications.No other issues have been reported by the customer post the service visit and the service actions performed resolved the reported issue.Siemens headquarters support center (hsc) is reviewing the results provided by the customer.The cause for the discordant falsely elevated cal results is unknown.Siemens is investigating the issue.
Event or Problem Description
Two discordant, falsely depressed calcitonin (cal) results were obtained using immulite 2000 xpi.The initial results were reported and questioned by the physician(s).The samples were repeated using another immulite 2000 xpi.The repeat results were 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 depressed cal results.
Additional Manufacturer Narrative
The initial mdr 2432235-2019-00425 was filed on 15-nov-2019.Additional information (18-nov-2019): siemens headquarters support center (hsc) reviewed the results provided by the customer.Hsc found that calcitonin (cal) calibration was acceptable.The quality control (qc), patient clinical history, and list of medications were not provided.Siemens was unable to perform internal testing of the patient samples due to stability issue with the samples.The customer transitioned to a new reagent lot and did not observe any additional issues with cal.Based on the information provided, siemens cannot determine a probable root cause, and cannot rule out sample specific issues.Hsc reviewed internal data for cal lot 281 and the product was found within specifications.Siemens did not identify a product problem.Cal lot 281 is performing within specification.No further evaluation of the device is required.Section(s) h6 and h10 were updated to reflect the additional information provided on 18-nov-2019.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2019-00425 on 15-nov-2019 and siemens filed the supplemental mdr 2432235-2019-00425_s1 on 13-dec-2019.Corrected information (24-aug-2020): the correct date of event that the discordant, falsely depressed calcitonin (cal) results were obtained (section b3) is (b)(6) 2019 and not (b)(6)2019.Section b3 was updated.

• Brand Name: IMMULITE 2000 XPI - CAL
• Common Device Name: IMMULITE 2000 XPI - CAL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, LL55 4EL; EI LL55 4EL
• MDR Report Key: 9331230
• Report Number: 2432235-2019-00425
• Device Sequence Number: 2498057
• Product Code: JKR
• UDI-Device Identifier: 00630414961156
• UDI-Public: 00630414961156
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K023304
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2020

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: 02/29/2020
• Device Model Number: IMMULITE 2000 XPI - CAL
• Device Catalogue Number: 10381446
• Device Lot Number: 281
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/20/2019
• Supplement Date Received by Manufacturer: 11/18/2019; 11/18/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 12/13/2019; 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1