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

Model Number	IMMULITE 2000 XPI - HVG
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the (b)(6) result is unknown.Siemens is investigating the issue.Mdr 2432235-2019-00296, mdr 2432235-2019-00297, and mdr 2432235-2019-00298 were filed for the same event.
Event or Problem Description
One (b)(6) result was obtained with (b)(6) lot 303 on immulite 2000 xpi instrument.The initial result was not reported to the physician(s).The sample was repeated using the same immulite 2000 xpi instrument and hvg reagent lot.The repeat result was considered correct and was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, false negative hvg result.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2019-00299 on 20-aug-2019.Additional information (23-sep-2019): siemens headquarters support center (hsc) reviewed the data provided previously by the customer.Hsc reviewed sample handling by the customer and found the possibility of bubbles being present in the sample pre analysis.Review of internal data was performed, and no issues have been identified.Pre analytical handling cannot be ruled out for the non-reproducible sample results.Additional information (16-oct-2019): hsc reviewed sample id: (b)(6).The sample level sense was analyzed but found without issues, the dilution level sense was also analyzed but no anomaly was found.Additionally, the reagent level sense data was also reviewed, and errors were not found.The presence of foam or bubbles could not be determined as the level sense encoder values are consistent and performing without issues.Based on the information provided, the probable cause is inconclusive.The level sense performance of the instrument is working as expected.There is no evidence of a product nonconformance.Sample handling or pre-analytical cannot be ruled out.The customer indicated that they had another discordant hvg but did not provide any data or information related to the results.The instrument is working without issues.The cause for the discordant falsely depressed hvg sample result is unknown.Sections h6 and h10 were updated to reflect the additional information.Section b6 was updated to reflect a correction of the reported sample id.Mdr 2432235-2019-00296-s1, mdr 2432235-2019-00297-s1, and mdr 2432235-2019-00298-s1 were filed for the same event.

• Brand Name: IMMULITE 2000 XPI - HVG
• Common Device Name: IMMULITE 2000 XPI - HVG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, LL55 4EL; EI LL55 4EL
• MDR Report Key: 8913179
• Report Number: 2432235-2019-00299
• Device Sequence Number: 13524386
• Product Code: LGC
• UDI-Device Identifier: 00630414999784
• UDI-Public: 00630414999784
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K010878
• 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): 10/18/2019

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: 02/29/2020
• Device Model Number: IMMULITE 2000 XPI - HVG
• Device Catalogue Number: 10381333
• Device Lot Number: 303
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1