MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 HCG; IMMULITE 2000 XPI - HUMAN CHORIONIC GONADOTROPIN (HCG)

Model Number	IMMULITE 2000 - HCG
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2020
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 confirmed that all instrument maintenance was current and found no signs of system contamination.The cse found no related mechanical errors posted to the error log, no known shipping/receiving or facility storage issues, and all reagents and quality control (qc) were handled in accordance with their package insert instructions.The instrument and the qc results were performing within specification.Siemens headquarters support center (hsc) is reviewing the information provided by the customer.Mdr 2432235-2020-00258 was also filed for the same event.
Event or Problem Description
One discordant, falsely depressed human chorionic gonadotropin (hcg) result was obtained using immulite 2000 xpi.The initial result was reported to the physician(s) and was questioned.A repeat result was performed later using the same immulite 2000 xpi and was considered correct.The correct result was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed hcg result.
Additional Manufacturer Narrative
The initial mdr 2432235-2020-00257 was filed on 31-mar-2020.Additional information (3-apr-2020): siemens headquarters support center (hsc) reviewed the information provided by the customer.The customer reported that the patients were redrawn a week later, and the hcg results increased and were positive for pregnancy at that time.Hsc found that hcg adjustment, quality control and other patient results from this time were acceptable.The customer did not go back and repeat the initial draws for either patient.The samples are not available for further investigation.Hsc cannot determine the cause of these discrepant results.Contributing factors such as sample integrity and/or preanalytical variables cannot be ruled out.A potential product issue has not been identified.The instrument is performing within specification.No further evaluation of the device is required.Sections h6 and h10 were updated to reflect the additional information.Mdr2432235-2020-00258-s1 was filed for the same event.

• Brand Name: IMMULITE 2000 HCG
• Common Device Name: IMMULITE 2000 XPI - HUMAN CHORIONIC GONADOTROPIN (HCG)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, LL55 4EL; UK LL55 4EL
• MDR Report Key: 9904454
• Report Number: 2432235-2020-00257
• Device Sequence Number: 13616864
• Product Code: DHA
• UDI-Device Identifier: 00630414961149
• UDI-Public: 00630414961149
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K990222
• 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
• Report Date (Section B): 04/08/2020

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: 05/31/2020
• Device Model Number: IMMULITE 2000 - HCG
• Device Catalogue Number: L2KCG2
• Device Lot Number: 451
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1