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

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained a discordant falsely elevated human chorionic gonadotropin (hcg) result on the immulite 2000 xpi instrument.It is unknown if the discordant result was reported to the physician(s).The customer used the same sample and instrument to perform repeat testing.The customer noted that repeat results were lower and reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the falsely elevated hcg result.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center (ccc).A customer service engineer (cse) was dispatched to the customer site.The cse checked the positions of the sample pipettor and reagent pipettor, sample diluter, reagent diluter, photomultiplier (pmt) shutter, tube lifter, and quality of the substrate and water.Siemens is investigating the event.Mdr 2247117-2022-00003 was filed for the same event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2247117-2022-00004 on 18-jan-2022.Siemens reviewed additional information regarding falsely elevated human chorionic gonadotropin (hcg) results and concluded no hardware-related malfunction with the immulite 2000 xpi instrument.Siemens healthcare diagnostics further investigated the issue and confirmed the potential for falsely elevated hcg results due to sample carryover.This can be observed when a sample is assayed for hcg immediately after an undiluted sample with a hcg value of >5000 miu/ml.This issue impacts serum and urine patient samples, as well as quality control samples and adjustors.The effect of carryover varies based on the concentration of the high hcg sample.Starting 2022-02-22 an urgent medical device correction (umdc, letter imc22-04.A.Us) was sent to us customers, and an urgent field safety notice (ufsn, letter imc22-04.A.Ous) was sent to outside the us (ous).The umdc and ufsn explain the potential for carryover from high hcg samples into the next sample assayed for hcg on the immulite 2000/immulite 2000 xpi, and provides instructions to the customers.Mdr 2247117-2022-00003_s1 was filed for the same event.

• Brand Name: IMMULITE® 2000 HUMAN CHORIONIC GONADOTROPIN (HCG)
• Common Device Name: IMMULITE® 2000 HUMAN CHORIONIC GONADOTROPIN (HCG)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis, gwynedd NJ LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; uk registration #: 3002806944; gwynedd, llanberis NJ LL55 4EL; UK LL55 4EL
• Manufacturer Contact: rolando hualpa ; 62 flanders-bartley rd; flanders, NJ 07836
• MDR Report Key: 13280489
• Report Number: 2247117-2022-00004
• Device Sequence Number: 4945212
• Product Code: DHA
• UDI-Device Identifier: 00630414961149
• UDI-Public: 00630414961149
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K990222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2022
• 2 Devices were Involved in the Event: 1 2

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: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 10381194
• Device Lot Number: 469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/24/2021
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2432235-03/04/2022-002-C
• Patient Sequence Number: 1
• Patient Sex: Unknown