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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI - HVG Back to Search Results
Model Number IMMULITE 2000 XPI - HVG
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2019
Event Type  malfunction  
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 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.
 
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.
 
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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 Key8913179
MDR Text Key209850959
Report Number2432235-2019-00299
Device Sequence Number1
Product Code LGC
UDI-Device Identifier00630414999784
UDI-Public00630414999784
Combination Product (y/n)N
PMA/PMN Number
K010878
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/29/2020
Device Model NumberIMMULITE 2000 XPI - HVG
Device Catalogue Number10381333
Device Lot Number303
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/30/2019
Initial Date FDA Received08/20/2019
Supplement Dates Manufacturer Received09/23/2019
Supplement Dates FDA Received10/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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