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	05/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the discordant falsely elevated cal results is unknown.Siemens is investigating the issue.Mdr 2432235-2019-00220 was filed for the same event.
Event or Problem Description
One discordant, falsely depressed calcitonin (cal) result was obtained using immulite 2000 xpi.The initial result was reported to the physician(s).The sample was repeated using siemens advia centaur and the new result was 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 cal results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2019-00220 on 21-jun-2019.Additional information (16-jul-2019): the headquarters support center (hsc) analyzed the results provided by the customer.The hsc found that based on heterophilic blocking tube (hbt) results, 3 of the 5 samples recovered with lower values and appear to have an unidentified interference which affected the immulite assay and not the advia centaur assay.The other two falsely elevated samples (samples 32 and sample 34) remained elevated and discordant versus the advia centaur.No samples were available for in house testing due to sample stability of the calcitonin.As the blocking tubes on these two samples did not generate lower results, nonspecific interferent cannot be ruled out.Siemens cannot determine the definitive root cause for these falsely elevated samples.Hsc reviewed in house data for immulite 2000 xpi - cal lot 274 and 279 and found that they met all release specifications.The customer stated they will be transitioning to the advia centaur as this platform appears to be less affected by interferences.Siemens did not identify a product problem.Section h6 was updated to reflect the additional information.The instrument is performing within specification.No further evaluation of the device is required.

• 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: 8724311
• Report Number: 2432235-2019-00221
• Device Sequence Number: 19264700
• Product Code: JKR
• UDI-Device Identifier: 00630414961156
• UDI-Public: 00630414961156
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K023304
• 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): 08/14/2019

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: 12/31/2019
• Device Model Number: IMMULITE 2000 XPI - CAL
• Device Catalogue Number: 10381446
• Device Lot Number: 279
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1