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

Model Number IMMULITE 2000 XPI - HVG

Device Problem Low Test Results (2458)

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

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant false (b)(6) result is unknown.Siemens is investigating the issue.Mdr 2432235-2019-00297, mdr 2432235-2019-00298, and mdr 2432235-2019-00299 were filed for the same event.

Event Description

One discordant, false (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 (b)(6) result.

Manufacturer Narrative

Siemens filed initial mdr 2432235-2019-00296 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.Mdr 2432235-2019-00297-s1, mdr 2432235-2019-00298-s1, and mdr 2432235-2019-00299-s1 were filed for the same event.

• Brand Name: IMMULITE 2000 XPI - HVG
• Type of Device: IMMULITE 2000 XPI - HVG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, LL55 4EL; EI LL55 4EL
• MDR Report Key: 8913168
• MDR Text Key: 196082492
• Report Number: 2432235-2019-00296
• Device Sequence Number: 1
• Product Code: LGC
• UDI-Device Identifier: 00630414999784
• UDI-Public: 00630414999784
• Combination Product (y/n): N
• PMA/PMN Number: K010878
• 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1